Recall Roundup: Medical device recalls fall in April 2025

Welcome to Recall Roundup, where we keep you updated on last month’s FDA medical device recalls!

The FDA categorizes recalls—which can range from small corrections to requests for products to be destroyed—from Class III (least dangerous) to Class I (most dangerous).

Though the FDA posted 200 recalls from April 1 to 30 on its medical device recall online database, the agency’s recall webpage only labeled a single recall as a Class I. (The rest were presumably Class II or III.)

This is the lowest number of Class I recalls of any month since Healthcare Brew launched this series in October 2024.

The recall. The sole April Class I recall mentioned on the FDA’s webpage is a mobile power unit (MPU) used with Abbott’s HeartMate II and HeartMate 3 left ventricular assist systems. Abbott said in a March 13 notice there was an electrical component issue in MPUs distributed between April 2024 and February 2025, which could cause them to suddenly shut off or otherwise malfunction. MPUs with certain serial numbers should be returned for replacement, particularly if they are having issues. Abbott has not reported any serious injuries or deaths from this issue, the FDA said in a notice current as of April 24.

Early alerts. There were also two early alerts as part of a communications pilot that aims to inform the public about potentially dangerous devices before they are officially recalled. Conavi’s diagnostic intravascular catheter earned an early alert in April after one reported incident where a sheath fell off into a patient’s body while in use. The PowerPICC intravascular catheter is also on early alert after manufacturer Becton, Dickinson and Company and its subsidiary Bard Access Systems pulled the product from market following 10 reportedly serious injuries.