FDA Class One Recall of Faulty Heart Batteries

U.S. Food and Drug Administration (FDA) issued a class one recall of batteries used in a heart-assist device. Everyday Health confirms this reflects their highest level of concern. That’s because the Medtronic heartware ventricular assist device system supports weak blood flow leaving the left ventricle of the heart. The FDA class one recall of faulty heart batteries is therefore a serious matter for this class of heart patients.

The FDA Class One Recall of Faulty Heart Batteries

The left ventricle of the heart pumps blood into the aorta, which then distributes the oxygenated fluid throughout the body. The Medtronic heartware ventricular assist device system supports this process, if the natural system is under performing. It is an implant device, with a cable to a compact external controller and battery pack that clips to the user’s belt.

In this way the external batteries allow the user to regain their normal mobility, and continue much as they did before their condition developed. But first, here are details of the product under recall according to U.S. Food and Drug Administration:

Product Name: Medtronic HVAD Batteries
Model Numbers: 1650DE
Devices Being Recalled: 23,372
Dates distributed: January 1, 2009 to present
Date Initiated by Firm: June 28, 2022

This Affects Me: What Should I Do Now?

Medtronic is recalling the batteries because they unexpectedly fail. When this occurs, they may be unable to power the controller, unable to accept charge from the battery charger, or appear to remain charged when in use.

Users should therefore do the following while they wait further advice: