Analysis Of Medical Device Product Recalls: Insights From The MAUDE Database

Abstract

Background: Medical device recalls are crucial for patient safety, and analysing patterns and causes is key to improving device safety and regulations. The MAUDE database, maintained by the FDA, holds detailed reports of adverse events, including recalls. This study analyses recall trends and FDA-determined causes, focusing on device classes, review panels, and recommendations to enhance safety and oversight.

Materials and methods: We conducted a retrospective analysis of medical device recall data from the MAUDE database, covering January 1, 2020, to July 31, 2024. The data was analysed to categorize recalls by device type, cause, reason, and outcomes, offering insights into recall effectiveness and recommendations for improving device safety.

Results: A total of 2500, recalls were analysed from the MAUDE database. Among these the majority of recalls, 1,622, were classified in this analysis as Open 3 and 69 had complete recall status.

Conclusions: Our analysis of medical device recalls from the MAUDE database highlights key trends, causes, and outcomes, providing valuable insights into the effectiveness of current recall practices. By identifying patterns across device types and recall reasons, we offer recommendations to enhance regulatory oversight and improve device safety, ultimately aiming to reduce patient risk and strengthen the recall process.