Medtronic, after having identified welding defects with some of the batteries used in its HeartWare HVAD pumps last year, is asking patients and physicians to return 12 more batteries so that the company can conduct further engineering analysis.
The Food and Drug Administration posted the medical-device correction on Monday morning, one of several recalls for the heart pump since it was pulled from the market in 2021. The device, which consists of the pump, and an external battery and controller, was implanted in patients who are awaiting a heart transplant, or as a more permanent solution.
Medtronic first identified the welding problem with the batteries in May 2022, noting that if both batteries in the controller malfunctioned, it could result in the pump stopping due to loss of power. In June, Medtronic found a second…