Medtronic Recalls Fresh Batch of HeartWare HVAD System Batteries

Medtronic Recalls Fresh Batch of HeartWare HVAD System Batteries. Last year, Medtronic issued virtually monthly safety alerts connected to its now-defunct HeartWare Ventricular Assist Device (HVAD). This year, they seem to be continuing that trend.

Last week, Medtronic sent a letter (PDF) to a select group of ventricular assist device administrators on behalf of various healthcare organizations, marking the first recall of the heart pump this year. The manufacturer has contacted the affected customers to request the return of specific HVAD batteries due to a welding issue that could result in the batteries failing to work as intended.

Medtronic initiated the recall to continue its “engineering analysis” of the defective batteries, and it only applies to 12 batteries distributed worldwide. Following up on two separate safety notices given to healthcare professionals by Medtronic last summer, this recall expands upon those warnings.

In May, the company decided to replace the old components with new ones, so it recalled just one batch of HVAD batteries, which amounted to a total of 429 units. In a letter (PDF) that was sent out at the time, Medtronic stated that it had found a welding issue that might prohibit the battery from being able to keep a full charge, recharge correctly, or even cause it to stop providing any power at all.

In the event that this occurs, it will cause a low battery alarm to be activated on the device, which will alert users to either immediately recharge or replace the battery, as well as check that a backup power supply is available. However, if a single pump is powered by both a primary battery and a backup battery, and both of those batteries fail, the device will stop functioning altogether.

Medtronic issued the recall in May after receiving complaints about three of the impacted batteries. In one instance, the patient was not harmed by the failed battery because it was linked to a backup power source. However, the other two batteries were linked to the same HVAD system, and when they failed at once, the pump stopped working, causing the demise of the patient.

After a month, Medtronic informed all caregivers who were treating patients with the heart pump installed that the safety event had been expanded. Seven complaints involving eight batteries had been received by the firm by that point; with the exception of the previously mentioned patient fatality, the other complaints resulted in “no or negligible patient harm,” as stated in a June letter. In the same month, the FDA issued its most severe recall classification—Class I—for the batch of HeartWare batteries that had been recalled in May.

According to the notification sent out last week, Medtronic has analyzed electrical data stretching back to 2019, and has found signatures in that data that are indicative of faulty batteries. As such, the most recent recall is a part of a larger initiative to collect batteries with certain indicators for future study.

The company had this to say regarding the process: “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.”

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