Medtronic issues another battery recall for HeartWare Ventricular Assist Device

por John R. Fischer, Senior Reporter | February 01, 2023
Business Affairs European News Parts And Service
Medtronic has recalled 12 batteries used with its HeartWare Ventricular Assist Device. (Photo coutesy of Medtronic)
Medtronic is once again recalling batteries for its HeartWare Ventricular Assist Device (HVAD) due to a welding issue that causes them to malfunction.

The HVAD device, which was taken off the market in 2021, provides hemodynamic support for advanced, refractory left ventricular heart failure.

In a January letter sent to ventricular assist device coordinators for several healthcare facilities, the company said it traced the issue to certain electrical signals, and was recalling 12 batteries distributed worldwide to continue its “engineering analysis” of the faulty batteries.

The recall is a continuation of previous ones issued in May 2022, which was expanded a month later.

“Although actions have been taken to improve control of the welding process, batteries manufactured prior to the improved weld detection methods may still be in use, and it is not known if this new electrical data screen will identify all latent weld nonconformances,” said Medtronic in its January recall notice.

Medtronic examined battery electrical data going all the way back to 2019.

It previously issued a recall back in May for a single lot of 429 HVAD batteries after discovering a welding defect that could prevent them from recharging properly, holding a complete charge, or powering the device altogether.

This could trigger a low battery alarm, warning users to quickly recharge or replace the battery and ensure they have a backup power source. But if two malfunctioning batteries are used as both primary and backup power sources, it could cause the pump to stop working completely. This led to the death of one patient, prompting the recall.

Medtronic expanded the recall in June following seven complaints about eight batteries. None of these incidents resulted in patient harm. Nevertheless, the FDA ranked the recall a Class I rating, its most serious.

Medtronic halted sales in June 2021 after evidence linked the device to stroke, mortality and other adverse neurological incidents. Previous recalls for the device had been issued in the past.

Additionally, the solution has not met federal standards since as early as 2014, and received more than 3,000 reports of deaths by the end of 2020. This prompted a congressional investigation into how the FDA regulated the solution amid these safety issues.

For the January case, Medtronic maintains its previous patient management recommendations, continuing to urge users to always keep two power sources connected to their pumps to fully charge spare batteries on hand.

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