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Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis
Claudia See1, Maryam Mooghali2, Sanket S Dhruva3
1Department of Medicine, University of California, San Francisco, San Francisco, California (C.S.).
Insights
Class I recalls of cardiovascular devices, often due to design flaws, impacted thousands of patients annually. Few devices underwent rigorous premarket or postmarket clinical testing, highlighting patient safety concerns.
Area of Science:
- Medical Device Safety
- Regulatory Science
- Cardiovascular Medicine
Background:
- Class I recalls represent the most severe FDA designation for medical devices, signifying potential for serious adverse health consequences or death.
- Cardiovascular devices constitute a significant portion (one-third) of all Class I recalls, underscoring the critical need for patient safety evaluation.
Purpose of the Study:
- To analyze the characteristics of Class I recalls for cardiovascular devices issued between 2013 and 2022.
- To evaluate the clinical evidence supporting the authorization of these recalled cardiovascular devices.
Main Methods:
- A cross-sectional study identified Class I cardiovascular device recalls from the FDA's annual logs (2013-2022).
- Data on device regulatory history and clinical evidence (premarket testing, postmarket surveillance) were extracted from FDA decision summaries.
- Quality of clinical studies, including endpoint selection (clinical vs. surrogate, composite use), was analyzed.
Main Results:
- 137 Class I recall events affected 157 cardiovascular devices; 71.3% were moderate-risk 510(k) devices and 28.7% were high-risk premarket approval (PMA) devices.
- Device design was the most common recall cause (31.4%). 26.8% of devices experienced multiple Class I recalls.
- Only 19.1% of devices underwent premarket clinical testing; most studies used surrogate or composite endpoints. Postapproval studies were delayed in 48.9% of PMA devices, and no 510(k) devices had postmarket surveillance.
Conclusions:
- Cardiovascular devices with Class I recalls were rarely subjected to comprehensive premarket or postmarket clinical testing.
- Recalls frequently impacted thousands of units, raising significant patient safety concerns.
- The findings suggest a need for enhanced regulatory scrutiny and clinical evidence requirements for cardiovascular devices.
Background:
Cardiovascular 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.
Objective:
To characterize Class I recalls of cardiovascular devices and the clinical evidence supporting authorization.
Design:
In 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.
Setting:
The FDA Medical Device Recalls database.
Participants:
Cardiovascular devices with Class I recalls.
Measurements:
Recalls 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).
Results:
From 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.
Limitation:
Details about clinical testing may be missing from FDA summaries.
Conclusion:
Cardiovascular devices with Class I recalls were infrequently subjected to premarket or postmarket testing, with recalls affecting thousands of patients annually.
Primary Funding Source:
None.
