A year after Medtronic ceded the LVAD market to Abbott, it has yet another Class I recall involving its HeartWare Ventricular Assist Device pumps still implanted in patients.
The FDA today designated a Medtronic recall involving the HVADs as Class I — its most serious level. It’s the second Class I recall designation for the HVADs this month.
This time around, the Class I recall involves a potential welding defect affecting a specific lot of external batteries for the HVADs. Medtronic became aware of complaints that the battery had stopped providing power or failed to hold a charge. The medtech giant is retrieving the affected lot of batteries and replacing them.
“The wellbeing and experiences of patients implanted with the HVAD pump are vitally important to us. Although Medtronic no longer distributes the HVAD System, we are committed to ongoing quality assessments and control measures to further patient safety and therapy effectiveness,” Medtronic spokesperson Erika Winkels said in a statement shared with MassDevice and Medical Design & Outsourcing.
Fridley, Minnesota–based Medtronic reports one death associated with the latest recall and two complaints in the affected lot, according to the FDA. The agency said the recall involved 429 batteries manufactured April 13, 2021 to April 19, 2021 and distributed April 20, 2021 to July 19, 2021.
About two weeks ago, the FDA issued another Class I designation for a Medtronic recall of 1,614 HVAD pump implant kits due to defective welds connected to at least one death.
Medtronic in June 2021 stopped selling HVADs — and advised clinicians to stop implanting them — amid a serious, global recall following complaints that the internal pump may fail or delay to restart. Abbott responded by announcing that it has the capacity to support the growing demand for mechanical circulatory support devices with its HeartMate 3 heart pumps.