Heartware, Inc. recalls HeartWare HVAD Pump Implant Kit, REF 1125
Recalled Product
HeartWare HVAD Pump Implant Kit, REF 1125
Hazard / Issue
Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.
Issued by
FDA
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