Abstract 343: Cardiovascular Device Recalls in 2012

Abstract

Background: For the fiscal year 2012, the Food and Drug Administration (FDA) classified 1,190 medical device recalls. Of these, 132 (11%) were for cardiovascular (CV) devices. Class I recalls, representing the greatest health risk, result from finding a reasonable probability that device use will cause serious adverse health consequences or death. FDA approves or clears devices for the US market through either the Pre-Market Approval (PMA) pathway or, more commonly, through a substantial equivalence determination known as 510(k) clearance. Methods: Recalled devices were categorized into nine broad CV device groups. Recall data was included on class, marketing path, and the number of distributed devices. Results: PMA devices represented 14% of the CV device recalls and 510(k) devices represented 82%. There were four Class I recalls -- two PMA and two 510(k). Circulatory support and surgical (CS) was the device group with highest number of recalls (43, 33%). Physiologic monitors (PM) had the second highest (28, 21%) and Vascular catheters (VC) the third highest (17, 13%). The remaining recalls (44, 33%) were included in these device groups: Implanted pacemakers, defibrillators and leads (ID), Non-implantable EP devices (EP), External defibrillators (ED), Vascular access (VA), Stents/grafts/valves (SG), and Others (OT). Over 16 million distributed devices were recalled in the year, with the highest average number per recall seen in the CS group and the lowest in the EP group. Class I recalls varied based both on market pathway and the number of distributed devices. Thoratec’s Heartmate II - PMA - 3,852 St Jude Medical’s Riata - PMA -128,000 Draeger’s Infinity System - 510(k) -1 Cardiac Science Powerheart - 510(k) -12,782 Conclusion: Most of the CV recalls in 2012 were 510(k) devices that were in the CS, PM, or VC device group. Failures in medical devices pose risk to the public and FDA strives to mitigate risk to the public health through the promotion of safe and effective devices, and the removal from the US market of those determined to be unsafe or ineffective.