Recall Z-1428-2020— Heartware, Inc.
Class I · Ongoing
Class I FDA medical device recall by Heartware, Inc., initiated 2020-01-23. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.. Reason: Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port..
- Recalling firm
- Heartware, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2020-01-23
- Firm location
- Miami Lakes, FL, United States
Product description
HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
Reason for recall
Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
Data sourced from openFDA. This site is unofficial and independent of the FDA.