Recall Z-1323-2013— Heartware Inc
Class II · Terminated
Class II FDA medical device recall by Heartware Inc, initiated 2012-12-27, terminated 2013-07-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device). Reason: HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector..
- Recalling firm
- Heartware Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-12-27
- Terminated
- 2013-07-09
- Firm location
- Miami Lakes, FL, United States
Product description
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Reason for recall
HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.
Data sourced from openFDA. This site is unofficial and independent of the FDA.