Recall Z-1726-2015— HeartWare Inc
Class I · Ongoing
Class I 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). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.. Reason: Complaints with the HVAD Retraction of Pins within the driveline connector..
- Recalling firm
- HeartWare Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2015-04-29
- Firm location
- Miami Lakes, FL, United States
Product description
HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.
Reason for recall
Complaints with the HVAD Retraction of Pins within the driveline connector.
Data sourced from openFDA. This site is unofficial and independent of the FDA.