Study highlights limits of premarket evaluation for identifying recalls of high-risk medical devices
More than one-third of high-risk therapeutic medical devices approved over the last decade were subject to serious recalls, but the lack of consistent characteristics of these recalled devices suggests the need for greater postmarket surveillance, according to the results of a recent cross-sectional study published in JAMA.
While various device types, characteristics of pivotal studies, and devices that required a post-approval study were more likely experience serious recalls, there were no major consistent associations between serious recalls and characteristics of a device, premarket clinical evidence, or regulatory characteristics, the researchers said.
“[T]he absence of significant associations between most observable device, premarket study, and regulatory characteristics and recalls underscores the limitations of premarket evaluation alone in predicting postmarket safety,” Maryam Mooghali, of the department of internal medicine at Yale School of Medicine, and colleagues wrote. “Together, these findings emphasize the critical importance of robust postmarket surveillance to identify and mitigate device-related safety risks as devices are adopted into broader clinical use to ensure patient safety.”
Mooghali and colleagues evaluated 193 high-risk therapeutic medical devices from the premarket approval (PMA) pathway between January 2014 and December 2023, identifying the proportion of devices subject to serious recalls and class I recalls. The researchers also compared the characteristics of each device, the pivotal study leading to its approval, and regulatory characteristics such as breakthrough therapy designation status, whether an advisory committee meeting was held, and if the device required a post-approval study.
Overall, 72.0% of devices were implantable, 31.1% had life-supporting or life-sustaining status, 51.3% were cardiovascular devices, and 29.5% were first-in-class. There were 68 recalls (35.2%) through July 2025, with 15 devices (7.8%) having more than one recall, and 20 devices (10.4%) experiencing one or more class I recalls. Less than half (44.2%) of recalls had been terminated by July 2025, and the median time to recall was 2.6 years after approval. Most recalls were due to premarket causes (71.7%) rather than postmarket causes (10.6%). Reasons for recalls varied, but most commonly included design or selection issues (37.2%) or process control issues (18.6%).
Devices that had life-supporting or life-sustaining status, when compared to devices without that status, were also more likely to experience serious recalls (46.7% vs 30.1%; P = .02) or class I recalls (23.3% vs 4.5%; P < .001), while cardiovascular devices were subject to significantly more class I recalls compared to noncardiovascular devices (16.2% vs 4.3%; P = .004).
Pivotal study design also impacted the likelihood of recalls, and devices linked single-arm studies without controls (33.3%), single-arm studies with non-current controls (12.4%), and multiple-arm studies with concurrent controls (6.3%) were significantly more likely to experience class I recalls (P = .03). Serious recalls were significantly more likely among devices with required postapproval studies compared to devices without postapproval studies (40.0% vs 22.6%; P = .04).
The researchers noted there were no other significant associations between other device characteristics, pivotal study characteristics, and regulatory characteristics and the initiation of a serious recall.
Mooghali and colleagues said that recalls being initiated years after approval and affecting thousands of units suggests “serious postmarket safety events affected a meaningful proportion of high-risk devices and often became apparent only after devices were used in larger patient populations and followed for periods longer than the median 6 to 9 months in pivotal studies.”
The researchers proposed the use of unique device identifiers within health systems to track devices more precisely and aid in postmarket safety surveillance and recall management. “[R]ecalls may have multifactorial causes, and reliable tracking of devices in clinical settings could help identify device-related safety concerns more effectively,” they said.
