Recall Z-1813-2013— HeartWare Inc
Class II · Terminated
Class II FDA medical device recall by HeartWare Inc, initiated 2013-05-16, terminated 2019-08-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device). Reason: Potential to electrostatic discharged (ESD).
- Recalling firm
- HeartWare Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-16
- Terminated
- 2019-08-05
- Firm location
- Miami Lakes, FL, United States
Product description
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Reason for recall
Potential to electrostatic discharged (ESD)
Data sourced from openFDA. This site is unofficial and independent of the FDA.