Medtronic, Inc. is recalling a single lot of HeartWare Ventricular Assist Device (HVAD) System batteries because of welding defects that may cause separation of the two cell battery packs used to power the system, according to an alert on the US Food and Drug Administration (FDA) website.
“The welding defect may cause the battery to malfunction and no longer provide power or prevent the battery from holding a full charge or properly recharging,” the FDA says.
The agency has identified this as a class I recall, the most serious type because of the potential for serious injury or death.
Medtronic reports one death associated with this recall and two complaints in the affected lot.
Back in April, as reported by theheart.org | Medscape Cardiology, Medtronic alerted providers that patients implanted with the Medtronic HVAD System…