After issuing near-monthly safety warnings related to its discontinued HeartWare Ventricular Assist Device (HVAD) last year, Medtronic is already continuing the trend in 2023.
The heart pump’s first recall this year arrived last week, when Medtronic sent a letter (PDF) to a handful of ventricular assist device coordinators representing several healthcare facilities. The devicemaker is asking those customers to return certain HVAD batteries that have been identified as potentially having a welding issue that could cause the batteries to malfunction.
Only 12 batteries distributed around the world are included in the recall, which Medtronic began in order to continue its “engineering analysis” of the faulty batteries.
This recall builds on a pair of safety notices that Medtronic sent to healthcare providers last summer.
In May, the company recalled a single lot of HVAD batteries, comprising 429 in total, with plans to replace them with new components. In a letter (PDF) at the time, Medtronic said it had discovered a welding defect that could prevent the battery from recharging properly or holding a complete charge, or even cause it to no longer provide any power whatsoever.
If that happens, it will trigger a low battery alarm on the device, warning users to quickly recharge or replace the battery and ensure that a backup power source is in place. However, if two malfunctioning batteries are being used as both the primary and backup power sources for a single pump, it could cause the device to completely stop working.
The May recall came after Medtronic received complaints related to three of the affected batteries. One of the batteries malfunctioned but caused no patient harm since that device was connected to a backup power source. The other two batteries, however, were both connected to the same HVAD system, so when they simultaneously malfunctioned and caused the pump to stop working properly, the patient died.
A month later, Medtronic expanded that safety event, notifying all healthcare providers overseeing patients implanted with the heart pump. By that time, the company had received a total of seven complaints linked to eight batteries; besides the previously reported patient death, all of the other complaints resulted in “no or negligible patient harm,” according to Medtronic’s June letter (PDF).
That same month, the FDA handed down a Class I rating—the agency’s most serious—to the May recall of the single lot of HeartWare batteries.
According to last week’s notice, Medtronic has examined battery electrical data dating back to 2019, allowing the company to identify certain electrical signatures linked to the malfunctioning batteries. The latest recall is therefore part of an effort to retrieve batteries marked with those indicators for further analysis.
Additionally, Medtronic added, “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.”
Because of that possibility, the company is upholding its previous patient management recommendations, which urge users to always keep two power sources connected to their pumps and to have fully charged spare batteries on hand just in case.