Recall Z-1751-2015— HeartWare Inc
Class II · Ongoing
Class II FDA medical device recall by HeartWare Inc, initiated 2015-04-29. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.. Reason: Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath..
- Recalling firm
- HeartWare Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2015-04-29
- Firm location
- Miami Lakes, FL, United States
Product description
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
Reason for recall
Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath.
Data sourced from openFDA. This site is unofficial and independent of the FDA.