Recall Z-0006-2017— HeartWare, Inc
Class I · Ongoing
Class I FDA medical device recall by HeartWare, Inc, initiated 2016-08-17. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.. Reason: Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults..
- Recalling firm
- HeartWare, Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2016-08-17
- Firm location
- Miami Lakes, FL, United States
Product description
HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Reason for recall
Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.
Data sourced from openFDA. This site is unofficial and independent of the FDA.