The FDA today designated a Medtronic recall involving the HVADs as Class I, the 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.