Medtronic's HVAD recall indicates the manufacturer has received more than 30 reports of the driveline covers becoming stuck, making it difficult to replace the controller.
Medtronic HVAD Heart Systems were linked to 3,000 deaths, according to FDA records, and the manufacturer removed it from the market in 2021. However, many individuals still have the heart device implanted in their body.
The unapproved software in the backup controllers has only been used twice to help prevent HVAD failures, and in one of those instances it failed and the patient was put into hospice care.
Recall comes about a year after the FDA decided the Medtronic HVAD risks outweighed the benefits provided by the heart transplant aids, and removed them from the market.
The HVAD battery problems have already led to at least one patient death, Medtronic reports.
The pump malfunction risk is the latest problem with Medtronic HVAD systems, which were removed from the market last year due to rampant defects and patient deaths.
The FDA received HVAD injury and death reports, and sent Medtronic warning letters, as early as 2014, but did not take significant action until a 2021 recall
