Research shows recalled heart devices had limited clinical testing

Retired cardiac devices often fail clinical trials, according to a study published last week in the journal Annals of Internal Medicine.

Cardiac devices account for a third of Class I recalls, the most serious Food and Drug Administration designation. Researchers found that the recalled devices “were rarely subjected to pre- or post-market testing, and the recalls affected thousands of patients per year.”

The authors analyzed cardiovascular devices with Class I recalls from 2013 to 2022. During that time, they found 137 Class I recalls involving 157 unique cardiac devices. The majority, about 71%, went through the FDA’s 510(k) pathway for intermediate-risk devices, while the rest went through the premarket approval (PMA) pathway for high-risk devices.

Devices going through the PMA pathway, such as implantable cardioverter-defibrillators and endovascular stent grafts, require clinical evidence of their safety and effectiveness, whereas devices going through the 510(k) pathway need only demonstrate that they are equivalent to an already approved product.

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

Limited clinical trials

The researchers found that only 30 of the 157 recalled heart devices had passed premarket clinical trials. The rest either did not or had no information available.

Of the 30 devices that underwent clinical testing, seven received 510(k) approval, 17 received PMA approval, and six received changes approved in PMA supplements.

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

Studies often used surrogate markers rather than clinical outcomes as an endpoint, and most studies had composite endpoints that may be more difficult to interpret.

“In other words, medical devices that were later withdrawn from the market due to safety issues often had little clinical evidence to support their original authorization,” the authors write.

The authors provided recommendations for strengthening the clinical evidence for cardiac devices, including requiring premarket testing for device types with high recall rates. The most commonly recalled cardiac devices included automated external defibrillators, intra-aortic balloon defibrillators, and implantable cardioverter-defibrillators.

The researchers also said the FDA could develop standard schedules for postmarket follow-up studies based on the relative risk of the device, as the European Union recently did. Or the agency could use its authority to require more postmarket studies for frequently recalled devices.

A key limitation of the study was the lack of information in the FDA’s recall database. Nearly half of recalls before 2017 did not include information on complaints, injuries or deaths. The study also included only Class I recalls, which may not capture the full range of patient safety issues for cardiac devices, the authors wrote.

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