Recalled heart devices often lack clinical testing, researchers found in a study published last week in the Annals of Internal Medicine. 

Heart devices account for one-third of Class I recalls, the Food and Drug Administration’s most serious designation. Researchers found the recalled devices “were infrequently subjected to premarket or postmarket testing, with recalls affecting thousands of patients annually.”

The authors analyzed cardiovascular devices with Class I recalls between 2013 and 2022. During that time, they found 137 Class I recalls affecting 157 unique heart devices. The majority, about 71%, went through the FDA’s 510(k) pathway for moderate risk devices, while the remainder went through the premarket approval (PMA) pathway for high-risk devices. 

Devices that go through the PMA pathway, such as implantable cardioverter-defibrillators and endovascular stent grafts, require proof of clinical evidence of safety and effectiveness, while devices that go through the 510(k) pathway need only prove they are equivalent to a product that’s already been authorized. 

The most common reason for recalls was device design, accounting for about 31% of events. More than half of the recalls recommended stopping further use, and one recommended explantation. 

Clinical testing limited

The researchers found that just 30 of the 157 recalled heart devices underwent premarket clinical testing. The remainder did not, or information was unavailable. 

The 30 devices that underwent clinical testing included seven that received 510(k) clearance, 17 with PMA approval and six with changes approved through PMA supplements. 

Most of the premarket studies were prospective, but they were not randomized or blinded, the authors of the report found. And 18 of the studies did not use a control group. 

Studies also frequently used surrogate markers instead of clinical outcomes as an endpoint, and the majority of studies had composite endpoints, which can be more difficult to interpret. 

“In other words, medical devices later recalled due to safety issues often had little clinical evidence supporting their original authorization,” the authors of the paper wrote.

The authors offered recommendations for strengthening clinical evidence for heart devices, including requiring premarket testing for device types with high rates of recalls. The most recalled heart devices included automated external defibrillators, intra-aortic balloons and implantable cardioverter-defibrillators. 

The researchers also said the FDA could develop standardized schedules for postmarket follow-up based on a device’s relative risk, as was recently done by the European Union. Or, the agency could use its authority to require more postmarket studies for frequently recalled devices. 

A key limitation of the study was missing information in the FDA’s recall database. Nearly half of recalls before 2017 don’t include information about complaints, injuries or deaths. The study also only considered Class I recalls, which may not capture the full range of patient safety considerations for heart devices, the authors wrote. 

The study was conducted by researchers at the University of California, San Francisco, Yale School of Medicine and Harvard Medical School.