Recall Z-1887-2016— Heartware, Inc.
Class I · Terminated
Class I FDA medical device recall by Heartware, Inc., initiated 2016-01-07, terminated 2020-03-27. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System is designed for in-hospital and out-of-hospital settings, including transportation via fixed-wing aircraft or helicopter.. Reason: Heartware Ventricular Assist System Battery Cell experiencing premature depletion..
- Recalling firm
- Heartware, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2016-01-07
- Terminated
- 2020-03-27
- Firm location
- Miami Lakes, FL, United States
Product description
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System is designed for in-hospital and out-of-hospital settings, including transportation via fixed-wing aircraft or helicopter.
Reason for recall
Heartware Ventricular Assist System Battery Cell experiencing premature depletion.
Data sourced from openFDA. This site is unofficial and independent of the FDA.