Recalled heart devices had limited clinical testing, study finds

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

Cardiac devices account for a third of Class I recalls, the Food and Drug Administration’s most serious designation. The researchers found that the recalled devices “rarely undergo premarket or postmarket testing, and the recalls affect thousands of patients each year.”

The authors analyzed cardiovascular devices with Class I recalls between 2013 and 2022. During that time period, they found 137 Class I recalls affecting 157 unique cardiac devices. The majority, approximately 71%, went through the FDA’s 510(k) pathway for intermediate-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 clinical evidence of safety and effectiveness, while devices that go through the 510(k) pathway only need to demonstrate that they are equivalent to an already authorized product.

The most common reason for recalls was device design, accounting for approximately 31% of incidents. More than half of the recalls suggested discontinuing further use, and one suggested an explanation.

Clinical tests are limited

Researchers found that only 30 of the 157 recalled heart devices had undergone clinical testing before being released to the market, while the rest had not or information was not available.

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

The report’s authors found that most of the premarketing studies were prospective but not randomized or blinded, and 18 of the studies did not use a control group.

Studies frequently used surrogate markers as endpoints rather than clinical outcomes, and many studies used composite endpoints, which may be more difficult to interpret.

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

The authors offered recommendations to strengthen clinical evidence for cardiac devices, including mandating premarket testing for device types with high recall rates. The most commonly recalled cardiac devices included automated external defibrillators, intra-aortic balloons, and implantable cardioverter-defibrillators.

The researchers also said the FDA could develop standardized schedules for post-market surveillance based on a device’s relative risk, as the European Union recently did. Or the agency could use its authority to require more post-market studies for frequently recalled devices.

One of the main limitations of the study was that the FDA’s recall database was incomplete. Nearly half of the recalls before 2017 did not include information on complaints, injuries or deaths. The study considered only Class I recalls, which may not cover the full scope of patient safety considerations for cardiac devices, the authors wrote.

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