Premarket Clinical Evidence Strength and Recalls of High-Risk Therapeutic Medical Devices
Maryam Mooghali, Faaizah Arshad, Vinay K. Rathi, Kushal T. Kadakia, Alexander O. Everhart, Joseph S. Ross, Sanket S. DhruvaImportance
High-risk medical devices approved through the US Food and Drug Administration (FDA) premarket approval (PMA) pathway may be supported by limited premarket clinical evidence, leaving uncertainties about safety. Whether device, premarket clinical evidence, or regulatory characteristics are associated with subsequent device recalls is unknown.
Objective
To examine the association between device, premarket clinical evidence, and regulatory characteristics and serious recalls among high-risk therapeutic devices.
Design and Setting
This cross-sectional study reviewed 193 high-risk therapeutic medical devices approved through the FDA’s PMA pathway between January 1, 2014, and December 31, 2023. Data were analyzed between August 2025 and December 2025.
Exposures
Device characteristics, premarket pivotal clinical study characteristics, and regulatory characteristics.
Main Outcome and Measure
The main outcome was occurrence of serious recall (Class I or II) and Class I (highest severity) recall.
Results
From 2014 to 2023, the FDA approved 193 original high-risk therapeutic medical devices through the PMA pathway. As of July 31, 2025, a total of 68 (35.2%) were subject to at least 1 serious recall, with a median (IQR) of 2.6 (1.5-4.6) years from approval to first recall; 20 (10.4%) devices were subject to at least 1 Class I recall. Life-supporting or life-sustaining devices more often had serious recalls (28 of 60 [46.7%] vs 40 of 133 [30.1%];
Conclusions and Relevance
In this cross-sectional study, more than one-third of high-risk therapeutic medical devices were subject to serious recalls. Because device, premarket clinical evidence, and regulatory characteristics were not consistently associated with serious recalls, robust postmarket surveillance is needed to ensure patient safety.