Device Recalls Research Articles

Clarification of Alcon Device Recalls

Clarification of Alcon Device Recalls

Faster Device Recall Notification Urged by Doctors

Faster Device Recall Notification Urged by Doctors

Faster Device Recall Notification Urged by Doctors

Faster Device Recall Notification Urged by Doctors

Radiologic Quality Assurance Device Recalled

Radiologic Quality Assurance Device Recalled

Surgical and Ob/Gyn Device Recall

Surgical and Ob/Gyn Device Recall

Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators

ContextUnanticipated pacemaker and implantable cardioverter-defibrillator (ICD) generator malfunctions sometimes warrant recall by the US Food and Drug Administration (FDA). Despite increasingly frequent device implantation, pacemaker and ICD recalls and safety alerts (advisories) remain poorly characterized.ObjectivesTo determine pacemaker and ICD generator advisory rates in the United States, to identify trends in these rates, and to examine their clinical and financial implications.Design and SettingAnalysis of weekly FDA Enforcement Reports issued between January 1990 and December 2000 to identify all advisories involving pacemaker or ICD generators in the United States. Recalls and safety alerts involving lead malfunctions were not included.Main Outcome MeasuresNumber of pacemakers and ICD generators in the United States subject to FDA recall or safety alert in 1990-2000; annual pacemaker and ICD advisory rates in the United States in 1990-2000; and estimated cost of device advisories.ResultsDuring the study period, 52 advisories (median [25th and 75th percentiles], 4 [4 and 7] per year) involving 408 500 pacemakers and 114 645 ICDs (523 145 total devices) were issued. Hardware malfunctions (35 advisories affecting 280 641 devices) and computer errors (10 advisories affecting 216 533 devices) accounted for 95% of device recalls. Implantable cardioverter-defibrillators were recalled more frequently than pacemakers (mean [SD], 16.4 [1.6] vs 6.7 [0.8] advisories per 100 person-years; P<.001). Between 1995 and 2000, the annual advisory rate increased for both pacemakers (P for trend <.001) and ICDs (P for trend = .02). An estimated 1.3 million device checks and analyses and 36 187 device replacements resulted from the advisories and cost approximately $870 million.ConclusionsPacemaker and ICD recalls and safety alerts occur frequently, affect many patients, and appear to be increasing in number and rate. With the growing number of device implants and expanding indications for device therapy, the number of patients affected by device advisories will likely continue to increase.

Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators.

Unanticipated pacemaker and implantable cardioverter-defibrillator (ICD) generator malfunctions sometimes warrant recall by the US Food and Drug Administration (FDA). Despite increasingly frequent device implantation, pacemaker and ICD recalls and safety alerts (advisories) remain poorly characterized. To determine pacemaker and ICD generator advisory rates in the United States, to identify trends in these rates, and to examine their clinical and financial implications. Analysis of weekly FDA Enforcement Reports issued between January 1990 and December 2000 to identify all advisories involving pacemaker or ICD generators in the United States. Recalls and safety alerts involving lead malfunctions were not included. Number of pacemakers and ICD generators in the United States subject to FDA recall or safety alert in 1990-2000; annual pacemaker and ICD advisory rates in the United States in 1990-2000; and estimated cost of device advisories. During the study period, 52 advisories (median [25th and 75th percentiles], 4 [4 and 7] per year) involving 408 500 pacemakers and 114 645 ICDs (523 145 total devices) were issued. Hardware malfunctions (35 advisories affecting 280 641 devices) and computer errors (10 advisories affecting 216 533 devices) accounted for 95% of device recalls. Implantable cardioverter-defibrillators were recalled more frequently than pacemakers (mean [SD], 16.4 [1.6] vs 6.7 [0.8] advisories per 100 person-years; P<.001). Between 1995 and 2000, the annual advisory rate increased for both pacemakers (P for trend <.001) and ICDs (P for trend =.02). An estimated 1.3 million device checks and analyses and 36 187 device replacements resulted from the advisories and cost approximately $870 million. Pacemaker and ICD recalls and safety alerts occur frequently, affect many patients, and appear to be increasing in number and rate. With the growing number of device implants and expanding indications for device therapy, the number of patients affected by device advisories will likely continue to increase.

Antiarrhythmic device advisories and recalls: managing an increasingly vulnerable process.

Antiarrhythmic device advisories and recalls: managing an increasingly vulnerable process.

Contaminated Radiation Protection Device Recalls Continue

Contaminated Radiation Protection Device Recalls Continue

Additional Radiation Protection Device Recalls Announced

Additional Radiation Protection Device Recalls Announced

Changing Trends in the Causes of Morbidity and Mortality Related to the Telectronics Accufix Permanent Pacemaker Lead: Lessons Learned From the First Three Years of Device Recall Management

Changing Trends in the Causes of Morbidity and Mortality Related to the Telectronics Accufix Permanent Pacemaker Lead: Lessons Learned From the First Three Years of Device Recall Management

Changing trends in the causes of morbidity and mortality related to the telectronics Accufix permanent pacemaker lead: lessons learned from the first three years of device recall management

Changing trends in the causes of morbidity and mortality related to the telectronics Accufix permanent pacemaker lead: lessons learned from the first three years of device recall management

Endomyocardial Biopsy Device Recalled Because Jaws May Not Close

Endomyocardial Biopsy Device Recalled Because Jaws May Not Close

FDA Recalls: How Do Pacemaker Manufacturers Compare?

To evaluate an apparent perception that there is no difference in reliability among the products of the major cardiac pacing system manufacturers, an extensive review of US Food and Drug Administration regulatory actions was performed. The study period was July 1974 through June 1987. The total number of affected devices was collected for each manufacturer. Available sales data were used to calculate their percentage of recalled products during two time periods. The percentage of potentially high-risk devices (Food and Drug Administration class I and II recalls) was high for one company, moderate for one, and relatively low for the rest. Potential biases in some other sources of reliability information, as well as implications for regulatory policies, are discussed. The data reported establish that there have been past deficiencies in recall management. Although further pacing device recalls are probable, appropriate early regulatory and manufacturer action should help to assure that both the immense cost and patient distress caused by pacer and related product problems in the past can be minimized in the future.

Computerized Medical Devices: Trends, Problems, and Safety

Virtually all of the medical devices utilizing electronics will contain a micro or minicomputer by 1990. These devices accounted for $7 billion in U.S. sales in 1984. Their capabilities can provide the means for new or greatly improved medical procedures, and ensure greater patient safety. However, these benefits can easily be compromised if ``computer safety'' is not practiced in the design, manufacturing, testing and clinical use of these devices. Along with a trend to wider usage, the number of recalls of medical devices due to computer-related problems has approximately doubled in the last five years. ``Computer-caused'' problems are often not recognized or reported as such, resulting in an underestimation of the prevalence of this type of problem. Our study of technical factors causing problems in computerized devices revealed that software quality assurance (SQA), the quality of the ac power, and electromagnetic interference are primary factors. Selected design and QA techniques that are well-known in military-aerospace industries can be used to prevent the most prevalent problems occurring in computerized medical devices, without significantly affecting overall device manufacturing costs.