FDA: Class I recall of Medtronic’s HVAD batteries

Editor's Note

The Food and Drug Administration (FDA), on June 23, identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) batteries as Class I, the most serious.

The recall for a single lot (Model Number:1650DE) of HVAD batteries was initiated because of welding defects that allow separation of the two cell battery packs. The welding defects may cause the batteries to malfunction and no longer provide power or prevent them from holding a full charge or properly recharging.

The HVAD is used as a bridge to cardiac transplants, for heart tissue recovery, or as destination therapy. Two complaints and one death have been associated with this recall.

Distribution dates were April 20, 2021, to July 19, 2021.