Recall Z-0005-2017— Heartware, Inc.
Class I · Terminated
Class I FDA medical device recall by Heartware, Inc., initiated 2016-06-08, terminated 2020-03-31. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartWare Ventricular Assist System Controller 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. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter. Reason: Loose connector ports in controller body..
- Recalling firm
- Heartware, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2016-06-08
- Terminated
- 2020-03-31
- Firm location
- Miami Lakes, FL, United States
Product description
HeartWare Ventricular Assist System Controller 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. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
Reason for recall
Loose connector ports in controller body.
Data sourced from openFDA. This site is unofficial and independent of the FDA.