Recall Z-2194-2021— Heartware, Inc.
Class I · Ongoing
Class I FDA medical device recall by Heartware, Inc., initiated 2021-06-03. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartWare HVAD Implant Kit, REF 1104JP. Reason: 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..
- Recalling firm
- Heartware, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2021-06-03
- Firm location
- Miami Lakes, FL, United States
Product description
HeartWare HVAD Implant Kit, REF 1104JP
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.