Medical Device Recalls Research Articles

Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis.

Cardiovascular devices account for one third of all Class I recalls, the U.S. Food and Drug Administration's (FDA) most severe designation, indicating a reasonable probability of "serious adverse health consequences or death." Understanding recalls and their causes is important for patient safety. To characterize Class I recalls of cardiovascular devices and the clinical evidence supporting authorization. In this cross-sectional study, cardiovascular device recalls from 1 January 2013 through 31 December 2022 were identified using the FDA's annual log. Information about devices was extracted from publicly available FDA decision summaries. The FDA Medical Device Recalls database. Cardiovascular devices with Class I recalls. Recalls were characterized by their causes and scope. Devices were characterized by their regulatory history (product code, special designations) and clinical evidence (premarket testing, postmarket surveillance). Clinical studies were analyzed for quality, including end point selection (clinical vs. surrogate, use of composites). From 2013 to 2022, there were 137 Class I recall events affecting 157 unique cardiovascular devices, of which 112 (71.3%) were moderate-risk 510(k) devices and 45 (28.7%) were high-risk premarket approval (PMA) devices. Recalls affected a median of 7649 units (IQR, 953 to 28 446) and were most commonly attributed to device design (43 [31.4%]). Forty-two (26.8%) devices had multiple Class I recalls. Thirty (19.1%) devices underwent premarket clinical testing (7 [6.2%] 510(k) devices, 17 [85.0%] PMA devices, and 6 [24.0%] PMA supplement devices). Most studies used surrogate (27 [79.4%]) and composite (24 [70.6%]) measures as primary end points. Twenty-two (48.9%) PMA devices had required postapproval studies, with 14 reporting delays. No 510(k) devices were subject to postmarket surveillance. Details about clinical testing may be missing from FDA summaries. Cardiovascular devices with Class I recalls were infrequently subjected to premarket or postmarket testing, with recalls affecting thousands of patients annually. None.

A Comprehensive Analysis of Class I Medical Device Recalls: Unveiling Patterns, Causes and Global Impacts.

In the landscape of medical device regulation, Class I recalls serve as pivotal indicators of potential risks, necessitating comprehensive analysis to unveil underlying patterns and causal factors. This research offers a detailed examination of Class 1 recalls, focusing on the critical aspects of device classification, review panel involvement, and the geographic distribution of recalling companies. Utilizing a robust dataset spanning multiple jurisdictions and device categories, this study reveals recurring trends in recall occurrences, providing insights into the regulatory mechanisms governing device safety assessments. Furthermore, it investigates the role of review panels in evaluating device safety and effectiveness, shedding light on their significance in the recall process. Moreover, the analysis explores the countries of origin of companies initiating recalls, offering insights into the global impact of regulatory actions on medical device manufacturers. By understanding the drivers behind recall decisions and their implications on a regional scale, regulatory authorities, and healthcare stakeholders can implement targeted measures to enhance patient safety and strengthen post-market surveillance practices.

Navigating the Landscape of Medical Device Advisories: A Special Report From the Canadian Heart Rhythm Society Device Advisory Committee

Cardiac implantable electronic devices (CIEDs) are often important for regulating cardiac rate and rhythm. Pacemakers and defibrillators are among the top 10 most implanted medical devices, with > 1.5 million devices implanted annually. Although millions of patients have benefited with improved quality of life and survival, CIED systems are becoming increasingly complex and do not always perform according to expectations. Advisory notices communicate important information about the safety and performance of a medical device to health care providers and patients. Medical device recalls are common, with > 35 unique device recalls in the past 5 years. From an ethical standpoint, CIED recalls highlight a range of considerations including the consent process, duty to report, how best to promote autonomous decision-making, trust in the health care system, as well as disproportionate effects of these considerations on equity-deserving groups. The purpose of the current article is to review and advise regarding the process around medical device advisory and recall, with a specific focus on clinicians caring for patients affected by these devices. We have sought the input of a lawyer, a patient advocacy group, and an ethicist to guide the clinical management of, and communications regarding, device recalls and advisories. Diligent surveillance and a clear, transparent patient consent process regarding these small but potentially serious device anomalies is paramount in ensuring patients believe they are safe and informed. Meaningful patient engagement helps to ensure optimal communication and disclosure mechanisms before implantation and throughout follow-up, accessibility of information in the initial implant and recall action process, and trust in health care systems and providers.

Female and Minority Representation in Top Management Teams and Medical Device Recalls

Female and Minority Representation in Top Management Teams and Medical Device Recalls

Novel Estimation of Medical Device Recalls from Defect Reports by Natural Language Processing

Novel Estimation of Medical Device Recalls from Defect Reports by Natural Language Processing

CEO Stock Ownership, Recall Timing, and Stock Market Penalties

Problem definition: Firms often delay the decision to recall faulty medical devices long after they become aware of a defect, thereby putting public safety at heightened risk. However, the factors contributing to these delays are not well-understood. To help address this gap, we examine whether and how CEO stock ownership influences the speed with which faulty medical devices are recalled and whether this influence varies with recall severity. We then examine whether the stock market penalizes firms differently based on recall decision-making speed and whether this penalty also varies with recall severity. Methodology/results: We collect data on 2,144 medical device recalls across 50 public medical device firms from 2002 to 2015. We use accelerated failure time models to test the effects of CEO stock ownership on the time-to-recall and event study methodology to examine how the time-to-recall influences stock market returns. Supplementary analyses shed further light on underlying mechanisms. Robustness checks demonstrate consistent results, including coarsened exact matching, reverse causality tests, Cox proportional hazard models, generalized linear regression models, and a mediation analysis. Firms whose CEOs possess greater ownership stakes recall medical devices more slowly, and this recall-slowing effect is accentuated for high-severity recalls. Delaying recalls magnifies the stock market penalty attributable to the recall, particularly for high-severity recalls. Managerial implications: Our study highlights an ownership characteristic of firms that are more likely to delay recalling faulty medical devices. Boards of directors can use insights from our study as they oversee product-quality decisions and determine the level and form of CEO compensation, and the FDA can use our findings to identify firms that might warrant extra scrutiny and better allocate its limited monitoring resources.Supplemental Material: The online appendix is available at https://doi.org/10.1287/msom.2021.0175 .

(438) An Inflatable Penile Prosthesis Manufacturer Recall: What do the Real Numbers Show from a Single High-volume Center?

Abstract Introduction The inflatable penile prosthesis (IPP) is considered the gold standard in the treatment of erectile dysfunction. As such, there have been a multitude of mechanical improvements over the recent decades. Despite these advances, there have been device recalls in the past. Some required revision surgery. A large retrospective study in 1995 from Drs. Wilson and Delk illustrated that revision surgery has an increased risk of infection of approximately 10%. However, this is most likely higher in lower volume institutions. In May of 2020, a major IPP device company released a letter issuing an urgent Class 2 medical device recall for their AMS 700 Momentary Squeeze Pumps (Boston Scientific, Marlborough, MA, USA) due to an increasing number of complaints due to failure of pump activation over a several year period. After investigation, a defective pump mold was found to be the etiology. There were only 2 pump molds; yet it is estimated that only up to 2% of devices would be affected. Objective We aim to investigate the actual device defect rate in clinical practice and to bring to light the cost of revision IPP surgery to our health system and patients. Methods We retrospectively reviewed charts from a single high-volume IPP surgeon from January 2018-December 2020 for virgin and replacement IPP patients. Those having Coloplast devices or malleable implants were excluded. Costs of revision surgery were also researched at the senior author’s facility. Results A total of 154 patients were identified. 42/154 (27%) patients were identified as removal and replacements and 112/154 (73%) were virgin cases. Of the 154 patients, 13/154 (8.4%) patients had pump failure. 5/112 (4.5%) were virgin cases and 8/42 (19%) patients were removal and replacements. These numbers do not include patients that have fickle pumps that were conservatively managed or implants that were identified as defective intraoperatively, which would greatly inflate these numbers. Cost analysis at our institution revealed direct costs that far exceed the price of the replacement device (list price $15,100; average is ~$14,000). However, these direct costs do not include the costs of convalescence, loss of work, or if any complications arise from the revision surgery. Conclusions We found that the stated rate of affected AMS 700 MS pumps to be approximately 4 times greater than previously stated at a rate of 8.4%. Including fickle pumps or grossly defective devices during the index surgery in this analysis would undoubtedly increase these numbers significantly. The company’s recall policy is also limited as it only considers malfunctions brought to its attention within 2 months of surgery. The cost to the patient and/or the hospital system far exceeds the cost of the replacement device itself. Further analysis should be performed. A more expeditious process for evaluating device complaints and more transparency from manufacturers should be implemented to improve patient satisfaction and outcomes. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific, Coloplast, Irrimax, MicrogenDx, Signati Medical, Endo, Pfizer, Procept Robotics

Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022

This cross-sectional study describes the inclusion of unique device identifier in recall notices for moderate- and high-risk medical devices in the US.

Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study.

Medical device recalls are initiated in response to safety concerns. Class I (highest severity) recalls imply a reasonable likelihood of serious adverse events or death associated with device use. Recalled devices must be identified, assessed, and corrected or removed, upon which a recall can be terminated. To characterize Class I medical device recalls and corresponding recalled devices. This was a cross-sectional study of Class I recalls posted on the Food and Drug Administration's annual log from January 1, 2018 to June 30, 2022 for moderate-risk and high-risk medical devices. Devices were categorized by therapeutic use, need for implantation, and life-sustaining designation; recalls were categorized by reason, status, and time elapsed. There were 189 unique Class I medical device recalls, including 151 (79.9%) for moderate-risk and 34 (18.0%) for high-risk devices. Sixty-five (34.4%) recalls were for cardiovascular devices, 36 (19.0%) for implanted devices, and 37 (19.6%) for life-sustaining devices. The median number of device units recalled in the US per recall notice was 4620 (interquartile range [IQR], 578-42,591), with 11 (5.8%) recalls associated with more than 1 million device units. Overall, 125 (66.1%) devices had multiple recalls, with a median of 4 (IQR, 3-11) recalls issued per recalled device. As of September 15, 2022, 50 (26.5%) recalls were terminated, with a median of 24 (IQR, 17.3-30.8) months elapsed between recall initiation and termination. Recalls were terminated more commonly among devices recalled once compared to those recalled multiple times (36.2% vs 19.2%; p=0.02) and for recalls that recommended discontinuing further use of affected devices compared to those that recommended device assessment and/or education of affected population (31.8% vs 18.2%; p=0.04). High-severity medical device recalls are common and affect millions of device units annually in the US. Recall termination takes a significant amount of time, putting patients at risk for serious safety concerns.

Medical Device Recalls for Electronic Components

Through the advancement of technology, an ever-increasing number of medical devices contain electronic components and sensors. As a result of these technological advances, smaller devices need more memory, sensors, processing power, and increased energy requirements. Ultimately, the performance of many medical devices is directly dependent on the functionality of these interconnected electronic components. In this article, medical device recalls are examined for malfunctions of electronic systems and components with respect to what system or component specifically did not perform as intended. From this examination, recalls related to electronic medical device systems and components are identified and grouped into common themes. By alerting the Food and Drug Administration to medical device failures, clinical engineering staff can help make manufacturers aware of issues that can be used to make future design changes or mitigations that can ultimately improve the performance and reliability of electronic medical devices.

Identification of Known Use-Related Problems in Artificial Intelligence Medical Imaging Devices

As Artificial Intelligence (AI) advances, it is included into more and more medical device systems to carry out these systems’ intended functions. Given AI’s ability to learn from real-world use and its capability to continuously improve performance, manufacturers of medical devices are utilizing AI to innovate their products to better assist health care providers. However, like application of other types of medical devices, the application of AI in medical care might pose different types of potential risks to the patients, the users themselves, and to the use environment. For manufactures to successfully ensure the safety of AI medical devices, it is crucial to identify known problems by investigating use-related, user interface, and user interaction in-cidents that have occurred in comparable medical devices. The objective of this study is to identify potential use-related problems of DeepView® Wound Imaging System that assesses the healing potential of thermal burn wounds by analyzing multispectral images with an ML algorithm. We use a variety of sources of information on reports and recalls of medical devices that are associated with deaths, serious injuries and mal-functions. After examining relevant reports and recalls, 19 use-related problems were identified. An in-depth analysis was then conducted, considering each identified use-related problem and determining how it relates to the specific features and functionality of DeepView® Wound Imaging System as well as identifying patterns and commonalities among them. The information gained from this analysis can be beneficial in enhancing the safety of AI medical devices by providing a deeper understanding of the reasons for failure, to avoid similar issues in the future, and ultimately to improve patient safety and public health.

Camouflage uncovered: what should happen next?

Recent publications have drawn attention to the fact that some brands of joint replacement may contain variants which perform significantly worse (or better) than their 'siblings'. As a result, the National Joint Registry has performed much more detailed analysis on the larger families of knee arthroplasties in order to identify exactly where these differences may be present and may hitherto have remained hidden. The analysis of the Nexgen knee arthroplasty brand identified that some posterior-stabilized combinations have particularly high revision rates for aseptic loosening of the tibia, and consequently a medical device recall has been issued for the Nexgen 'option' tibial component which was implicated. More elaborate signal detection is required in order to identify such variation in results in a routine fashion if patients are to be protected from such variation in outcomes between closely related implant types.

Review of approvals and recalls of US specific medical devices in general and plastic surgery

Review of approvals and recalls of US specific medical devices in general and plastic surgery

Software-related recalls in computer-assisted hip and knee arthroplasty.

Computer-assisted arthroplasty supports the surgeons in planning, simulating, and performing the replacement procedure, using robotic or navigation technologies. However, the safety of the technology has not been widely ascertained. Food and Drug Administration (FDA) database was interrogated about software-related recalls in computer-assisted arthroplasty, aiming to assess: (1) the incidence, (2) the root causes, and (3) the actions taken due to recalls. The Medical Device Recalls database was investigated about software-related recalls in computer-assisted hip and knee arthroplasty surgery, between 2017 and 2022. The incidence of the software-related recalls, the root causes according to FDA and manufacturers, and the corrective actions taken by firms were determined. Eighteen recall numbers could be identified (1.6%), corresponding to 11 recall events. A total of 4634 units were involved. The FDA determined root causes were: software design (66.6%), design change (22.2%), manufacturing deployment (1, 5.6%), and design manufacturing process (5.6%). Among the manufacturers' reasons for recalls, a specific error was declared in 16 cases (88.9%). In seven cases (43.8%), a coding error about lower limb alignment assessment was identified. Seventeen software-related recalls (94.4%) were classified as class 2; only one case was class 3 (5.6%). Return of the device was the main action taken by firms (8, 44.4%), followed by software update (7, 38.9%). Software-related recalls in computer-assisted hip and knee arthroplasty were quite uncommon among all the recalls, deemed non-life threatening and usually due to software design errors. The main actions taken by manufacturers were the return of the device or the software update.

Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance

Most regulated medical devices enter the US market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are "substantially equivalent" to 1 or more "predicate" devices (legally marketed medical devices with similar intended use). Most recalled medical devices are 510(k) devices. To examine the association between characteristics of predicate medical devices and recall probability for 510(k) devices. In this exploratory cross-sectional analysis of medical devices cleared by the US Food and Drug Administration (FDA) between 2003 and 2018 via the 510(k) regulatory submission pathway, linear probability models were used to examine associations between a 510(k) device's recall status and characteristics of its predicate medical devices. Public documents for the 510(k) medical devices were collected using FDA databases. A text extraction algorithm was applied to identify predicate medical devices cited in 510(k) regulatory submissions. Algorithm-derived metadata were combined with 2003-2020 FDA recall data. Citation of predicate medical devices with certain characteristics in 510(k) regulatory submissions, including the total number of predicate medical devices cited by the applicant device, the age of the predicate medical devices, the lack of similarity of the predicate medical devices to the applicant device, and the recall status of the predicate medical devices. Class I or class II recall of a 510(k) medical device between its FDA regulatory clearance date and December 31, 2020. The sample included 35 176 medical devices, of which 4007 (11.4%) were recalled. The applicant devices cited a mean of 2.6 predicate medical devices, with mean ages of 3.6 years and 7.4 years for the newest and oldest, respectively, predicate medical devices. Of the applicant devices, 93.9% cited predicate medical devices with no ongoing recalls, 4.3% cited predicate medical devices with 1 ongoing class I or class II recall, 1.0% cited predicate medical devices with 2 ongoing recalls, and 0.8% cited predicate medical devices with 3 or more ongoing recalls. Applicant devices citing predicate medical devices with 3 or more ongoing recalls were significantly associated with a 9.31-percentage-point increase (95% CI, 2.84-15.77 percentage points) in recall probability compared with devices without ongoing recalls of predicate medical devices, or an 81.2% increase in recall probability relative to the mean recall probability. A 1-SD increase in the total number of predicate medical devices cited by the applicant device was significantly associated with a 1.25-percentage-point increase (95% CI, 0.62-1.87 percentage points) in recall probability, or an 11.0% increase in recall probability relative to the mean recall probability. A 1-SD increase in the newest age of a predicate medical device was significantly associated with a 0.78-percentage-point decrease (95% CI, 1.29-0.30 percentage points) in recall probability, or a 6.8% decrease in recall probability relative to the mean recall probability. This exploratory cross-sectional study of 510(k) medical devices cleared by the FDA between 2003 and 2018 demonstrated significant associations between 510(k) submission characteristics and recalls of medical devices. Further research is needed to understand the implications of these associations.

Development and Application of Medical Device Recall Event Tracking System

A medical device recall event tracking system was designed, which can enable the users to obtain the recall, early warning and other information related to medical devices in time. The tracking system can timely obtain and release the recall information of medical devices, effectively improve the quality control of hospital medical devices, reduce the use risk of medical devices, and ensure the life safety of patients.

Cascading Failures in New Product Development

While product failures are harmful to both consumers and firms, extant research in technology management and innovation does not provide sufficient answers for why they occur. In this research, I investigate what causes firms to experience product failures when they develop new products through the exploitation of their existing stock of technological knowledge. I examine an underexplored condition where a firm’s existing technology has undiscovered flaws to show how these hidden defects affect its new product quality. I find that if a firm develops new products by building on its prior technology with hidden defects, the new products have a high risk of failure. I reason that a firm’s bias toward exploitation leads the firm to fall into a competency trap and to overlook failures in its new product development process. Moreover, I argue that new products which recombine technologies across a firm’s distant technological and/or organizational boundaries are less likely to fall into this persistence of failure. Using a unique dataset on medical device recalls and predicate devices, I provide empirical evidence supporting my arguments.

Exploration, Exploitation, and Failure Correction Speed: A problem Formulation Perspective

Product failures present a great risk to the responsible organization, its customers, and other stakeholders, but to a certain degree, may be unavoidable for boundedly rational organizations. As a result, an important strategic challenge for organizations is to effectively and quickly correct product failures. Drawing on the problem formulation perspective, we introduce and develop the concept of remedial comprehensiveness, which we suggest would play a key enabling role in product failure correction. We theorize that exploration tendencies increase the inputs of problem formulation, whereas exploitation is expected to increase the impediments, suggesting the former facilitates remedial comprehensiveness, and in turn, product failure correction. Analyses of 8,250 medical device recalls in the U.S. provide an overall support for our theory.

Oesophageal protection during AF ablation: real world registry data and mechanisms behind the therapeutic effect of tissue cooling

Abstract Funding Acknowledgements Type of funding sources: None. Background Oesophageal protection using a dedicated device to provide controlled active thermal protection of the oesophagus during atrial fibrillation ablation has been shown to be effective at reducing endoscopically detected oesophageal lesions. Real world registry data of this device and established evidence on the effect of cooling on localized tissue after thermal injury have been under review. Purpose To determine the safety of an oesophageal temperature control device by a review of real-world registry data on its clinical use during catheter ablation procedures and to clarify basic mechanisms of its therapeutic action by a literature review of scientific studies on cooling in the context of thermal injury. Methods The United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE), FDA Medical and Radiation Emitting Device Recalls, the Medicines and Healthcare products Regulatory Agency (MHRA) Medical Device Alerts and SwissMedic records of Field Safety Corrective Actions (FSCA) databases were reviewed for any device-related adverse events. A systematic literature review was conducted to clarify the findings from studies investigating the physiological processes behind the therapeutic effect of cooling after tissue thermal injury. Results Of over 20,000 oesophageal temperature control devices clinically used, 7976 were recorded as having been used for the purpose of oesophageal protection during left atrial catheter ablations. No adverse events occurred related to its use during left atrial catheter ablations. No case of clinically significant oesophageal injury was reported in a patient who had been protected by the oesophageal temperature control device. 208 research articles retrieved from PubMed and MEDLINE that met the search criteria were reviewed. The common finding in all the studies was that cooling had an anti-inflammatory and restorative effect via modulation of several immune-mediated pathways, local cellular function and genetic expression. Conclusions There have been no adverse events reported to date in real world clinical use of an oesophageal temperature control device during left atrial catheter ablations, for the purpose of active thermal protection. Literature review data suggests that there are complex biophysical and cellular effects from cooling that leads to its therapeutic effect but further work is required to define the mechanisms of action of thermal protection in this specific context.

CA-528-03 A REGISTRY REVIEW UPDATE OF 7120 CATHETER ABLATIONS FOR ATRIAL FIBRILLATION USING A DEDICATED ESOPHAGEAL TEMPERATURE CONTROL DEVICE FOR PROTECTION

Esophageal protection using a dedicated device to provide controlled active thermal protection of the esophagus during atrial fibrillation ablation has been shown to be effective. Randomized evidence from the IMPACT trial showed an 83.4% reduction in endoscopically detected esophageal lesions compared to standard care. Real world registry data of this device has been under review. To determine the safety of an esophageal temperature control device by an updated review of real-world registry data on its clinical use and any reported device-related adverse events. The following databases were reviewed for any reported esophageal temperature control device-related complications: The United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE), FDA Medical and Radiation Emitting Device Recalls, the Medicines and Healthcare products Regulatory Agency (MHRA) Medical Device Alerts and SwissMedic records of Field Safety Corrective Actions (FSCA). An internal registry (post-marketing follow up) database maintained by the manufacturer of the device was used to quantify the number used for each indication. Reported events underwent an updated review including any instances of device-related adverse events when used during catheter ablations. Of the 20,000 oesophageal temperature control devices used, 7120 were recorded as having been used for the purpose of esophageal protection during left atrial catheter ablations. A total of 5 events associated with the device were identified, all from the MAUDE database. Three were from 2017, one from 2018, and one from 2019. All involved its use in critical care or trauma patients and were related to user error or contraindicated patient selection; none resulted in serious harm to the patient. No adverse events occurred related to its use during left atrial catheter ablations. No case of clinically significant esophageal injury was reported in a patient who had been protected by the esophageal temperature control device. Real world registry data has shown no adverse events reported to date in 7120 uses of an esophageal temperature control device during left atrial catheter ablations, for the purpose of active thermal protection.