A median of 7,649 units were affected by recalls, which were most often related to device design
By Elana Gotkine HealthDay Reporter
TUESDAY, Sept. 17, 2024 (HealthDay News) — Cardiovascular devices with Class I recalls appear to be rarely subjected to premarket or postmarket testing, according to a study published online Sept. 17 in the Annals of Internal Medicine.
Claudia See, M.D., from the University of California in San Francisco, and colleagues characterized Class I recalls of cardiovascular devices and the clinical evidence supporting authorization in a cross-sectional study. The U.S. Food and Drug Administration annual log was used to identify cardiovascular device recalls from Jan. 1, 2013, through Dec. 31, 2022.
The researchers identified 137 Class I recall events from 2013 to 2022, affecting 157 unique cardiovascular devices; 112 and 45 (71.3 and 28.7 percent) were moderate-risk 510(k) and high-risk premarket approval (PMA) devices, respectively. Recalls affected a median of 7,649 units and were most often related to device design (31.4 percent). Multiple Class I recalls were seen for 42 devices (26.8 percent). Thirty of the devices (19.1 percent) underwent premarket clinical testing; surrogate and composite measures were used as primary end points in most studies (79.4 and 70.6 percent, respectively). Postapproval studies were required for 22 PMA devices (48.9 percent); 14 reported delays. None of the 510(k) devices required postmarket surveillance.
“Cardiovascular devices with Class I recalls were infrequently subjected to premarket or postmarket testing, with recalls affecting thousands of patients annually,” the authors write. “These findings illustrate the limited clinical evidence supporting the use of cardiovascular devices later found to have serious safety concerns.”
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