• Claudia See, Maryam Mooghali, Sanket S Dhruva, Joseph S Ross, Harlan M Krumholz, and Kushal T Kadakia.
• Department of Medicine, University of California, San Francisco, San Francisco, California (C.S.).
• Ann. Intern. Med. 2024 Nov 1; 177 (11): 149915081499-1508.

BackgroundCardiovascular devices account for one third of all Class I recalls, the U.S. Food and Drug Administration's (FDA) most severe designation, indicating a reasonable probability of "serious adverse health consequences or death." Understanding recalls and their causes is important for patient safety.ObjectiveTo characterize Class I recalls of cardiovascular devices and the clinical evidence supporting authorization.DesignIn this cross-sectional study, cardiovascular device recalls from 1 January 2013 through 31 December 2022 were identified using the FDA's annual log. Information about devices was extracted from publicly available FDA decision summaries.SettingThe FDA Medical Device Recalls database.ParticipantsCardiovascular devices with Class I recalls.MeasurementsRecalls were characterized by their causes and scope. Devices were characterized by their regulatory history (product code, special designations) and clinical evidence (premarket testing, postmarket surveillance). Clinical studies were analyzed for quality, including end point selection (clinical vs. surrogate, use of composites).ResultsFrom 2013 to 2022, there were 137 Class I recall events affecting 157 unique cardiovascular devices, of which 112 (71.3%) were moderate-risk 510(k) devices and 45 (28.7%) were high-risk premarket approval (PMA) devices. Recalls affected a median of 7649 units (IQR, 953 to 28 446) and were most commonly attributed to device design (43 [31.4%]). Forty-two (26.8%) devices had multiple Class I recalls. Thirty (19.1%) devices underwent premarket clinical testing (7 [6.2%] 510(k) devices, 17 [85.0%] PMA devices, and 6 [24.0%] PMA supplement devices). Most studies used surrogate (27 [79.4%]) and composite (24 [70.6%]) measures as primary end points. Twenty-two (48.9%) PMA devices had required postapproval studies, with 14 reporting delays. No 510(k) devices were subject to postmarket surveillance.LimitationDetails about clinical testing may be missing from FDA summaries.ConclusionCardiovascular devices with Class I recalls were infrequently subjected to premarket or postmarket testing, with recalls affecting thousands of patients annually.Primary Funding SourceNone.

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