Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis
Authors' conclusion
Cardiovascular devices with Class I recalls were infrequently subjected to premarket or postmarket testing, with recalls affecting thousands of patients annually.
Study context
- Population
- Cardiovascular devices with Class I Food and Drug Administration's (FDA) recalls, 2013–2022 (FDA Medical Device Recalls database)137 Class I recall events
- Participants
- 157 unique cardiovascular devices
- Exposure
- 510 devices vs premarket approval (PMA) devices
- 510(k)n = 112
- PMAn = 45
- Outcome
- Characteristics of Class I recalls and supporting clinical evidence
Methodological detailsDetails about clinical testing may be missing from FDA summaries
- Details about clinical testing may be missing from FDA summaries
Main finding
As reported in the abstract
- Units affected per recall (median, IQR 953 to 28 446)
- 7649
- Recalls attributed to device design
- 43 [31.4%]
- Devices with multiple Class I recalls
- 42 (26.8%)
- Devices with premarket clinical testing
- 30 (19.1%)
- Studies using surrogate primary end points
- 27 [79.4%]
- Studies using composite primary end points
- 24 [70.6%]
Observational data: associations, not effects.
Further findings
Premarket clinical testing
| Outcome | 510(k) | PMA |
|---|---|---|
| Postmarket surveillance / required postapproval studies | — not stated in the abstract | 48.9% |
— not stated in the abstract
- Premarket clinical testing — All devices with premarket clinical testing
- 30 (19.1%)
- Postmarket surveillance / required postapproval studies — PMA postapproval studies reporting delays
- 14
- Premarket clinical testing: PMA supplement 24.0%
Postmarket surveillance / required postapproval studies
- No 510(k) devices were subject to postmarket surveillance
Primary end points of premarket clinical studies
- Surrogate primary end point
- 27 (79.4%)
- Composite primary end point
- 24 (70.6%)
Devices with multiple Class I recalls
- Devices with multiple Class I recalls
- 42 (26.8%)
Original publication
Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis. Ann Intern Med. Published 17 September 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →