The U.S. Food and Drug Administration (FDA) has announced a Class 1 recall of the HeartMate II LVAS Pocket System Controller from Abbott-Thoratec.
The device is a power supply that connects to the implanted HeartMate II LVAS pump. It helps power the LVAS system. The FDA reported Abbott received 70 reports of malfunction, including 19 injuries and 26 deaths. All deaths occurred when patients tried to exchange controllers outside of a hospital setting.
In a March 29 letter, Abbott-Thoratec sent an urgent letter to affected customers, recommending the following actions:
- New patients will receive upgraded hardware and software (to include a fully upgraded system controller with new yellow alignment markings and new lead/driveline) from their ventricular assist device (VAD) coordinator.
- Existing patients will receive updated device software and alarm guides for both their primary and back-up controllers
- Abbott-Thoratec will contact all affected health care providers to coordinate office visits, and receipt of software updates and updated labeling.
The FDA encouraged healthcare professionals and patients to report adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.