Most recalled cardiovascular devices gained FDA approval with little to no clinical evidence
![A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]](/sites/default/files/styles/top_stories/public/2024-09/istock-1209664264.jpg.webp?itok=gQInU1vO)
A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]
“Although only 1% of FDA-authorized devices are subject to Class I recalls, these recalls affect millions of patients and take years to resolve,” wrote Kushal T. Kadakia, MSc, a healthcare policy researcher with Harvard Medical School, and colleagues. “Cardiovascular devices are the most common device type subject to Class I recalls, accounting for approximately one third. Although the frequency of Class I recalls is increasing, there is little information about what types of cardiovascular devices are affected or the most common reasons for recalls.”
Hoping to learn more, the group tracked FDA data from 2013 to 2022 to gain a better understanding of how each recalled device was originally approved—and why the recall was initiated in the first place.
How medical device recalls work in the United States
First, a bit of background about recalls: Medical device manufacturers and distributors issue voluntary recalls when they learn their products may be defective, misleading or associated with safety concerns. These recalls include full removals, where the device in question is removed from the market, and corrections, where “repair, modification, adjustment relabeling, destruction or inspection” can address the issue without requiring a full removal.
The FDA classifies all medical device recalls as Class I, Class II or Class III incidents. Class I recalls are the most serious; using the product in question is associated with significant adverse health consequences, including death. Meanwhile, Class II recalls involves devices that “may cause temporary or medically reversible adverse health consequences” and Class III recalls carry little to no risk of any such issue.
When companies issue a recall, they alert the FDA and share their strategy for identifying customers and, if needed, getting the product off the market. The FDA reviews that strategy and will often play a role in spreading information about the issue.
It is worth noting that some recalls are not voluntary. In rare instances, the FDA will issue a recall order of its own if it believes a company is failing to act.
Exploring the data: Cardiovascular device Class I recalls from 2013 to 2022
Kadakia et al. explored data from a total of 137 Class I recall events that affected 157 different cardiovascular devices. A majority (71.3%) of devices gained approval through the FDA’s 510(k) pathway, meaning the manufacturer had to prove it was similar to devices already being marketed in the United States. The other 28.7% of devices were approved using the FDA’s premarket approval (PMA) pathway, which requires premarket clinical evidence to be gathered by the manufacturer and sent to the FDA for review. However, 55.6% of those devices were PMA supplements and not original PMA submissions, meaning little (and sometimes no) clinical testing was required.
“Even when premarket clinical testing was conducted, evidence was usually generated from a single nonrandomized, unblinded clinical trial using surrogate measures with no active control. In other words, medical devices later recalled due to safety issues often had little clinical evidence supporting their original authorization,” the authors wrote.
The median number of units included in a recall was 7,649, the authors found. In addition, the most common reasons for recalls were device design issues (31.4%), process control (16.1%) and component part design or selection (7.3%). For another 15.3% of recalls, the cause was still under investigation.
When the recall included safety reports, the median number of incidents per recall was 13.5 and median number of injuries was two. Deaths were rare, but four separate recalls included reports of anywhere from 12 to 26 deaths.
The study’s authors also found that external defibrillators, intra-aortic balloon and control systems, and implantable cardioverter-defibrillators (ICDs) were the most commonly recalled cardiovascular device types. A total of 31.2% of recalled devices were implantable.
Ongoing issues with premarket, postmarket clinical testing
Kadakia and colleagues wrote that their own findings “extend prior research about low rates of rigorous premarket and postmarket clinical testing.”
For example, the group wrote, some studies do not follow patient outcomes long enough to capture possible safety issues. Also, steps taken to accelerate FDA approval may be doing patients a disservice.
“Premarket clinical studies frequently relied on surrogate markers and composite measures, which can enable quicker trial completion to assess effectiveness, but may not capture the full scope of clinically meaningful information needed to assess device safety,” the authors wrote.
The way PMA supplements are handled may also be another area the FDA and other policymakers need to review. Many cardiovascular devices gain approval through supplements used the 180-day track process; this means a significant change was made to a previously approved device, but it does not necessarily require new clinical data. Because the 180-day track process is regularly used with cardiovascular devices, the study’s authors suggested there may be an ongoing issue that needs to be corrected with this process.
“Ensuring the appropriateness of supplement selection and clarifying when modifications to device types over time require new clinical data could mitigate safety concerns,” they wrote.
A call for change
The group concluded its in-depth investigation by suggesting some potential changes to this process. Premarket testing should be more thorough, for example, for medical device types associated with an above-average recall rate. The FDA could even develop “standardized schedules for postmarket device follow-up according to a device’s relative risk,” which is already being done overseas in Europe.
“Policy reforms should also be paired with efforts to advance education about device regulation and safety, particularly among clinicians, among whom 4 in 5 report only a limited understanding of the FDA’s processes,” the authors wrote.
Click here to read the full analysis in Annals of Internal Medicine. Co-authors included first author Claudia See, MD, MBA, with the University of California, San Francisco, and others.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.