Premarket Clinical Evidence Strength and Recalls of High-Risk Therapeutic Medical Devices.

Abstract

Importance: 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%]; P = .02) and Class I recalls (14 of 60 [23.3%] vs 6 of 133 [4.5%]; P < .001) than non-life-supporting and life-sustaining devices. Cardiovascular devices more often had Class I recalls than noncardiovascular devices (16 of 99 [16.2%] vs 4 of 94 [4.3%]; P = .004). Class I recalls differed by pivotal study design: single-arm with no controls, 3 of 9 (33.3%); single-arm with nonconcurrent controls, 11 of 89 (12.4%); and multiple-arm with concurrent controls, 6 of 95 (6.3%) (P = .03). Devices with required postapproval studies had more serious recalls (56 of 140 [40.0%] vs 12 of 53 [22.6%]; P = .04) than those without. Other characteristics were not associated with recall likelihood.

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.