Device product
HeartWare HVAD Implant Kit, REF 1104JP
Z-2194-2021
Product summary
- Firm
- Heartware, Inc.
- Event
- Event 88197
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 63 units
- Official record key
device-enforcement:Z-2194-2021
Official wording
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.
Code information: GTIN: 00888707005838 All serial numbers
Distribution pattern: Worldwide distribution. US nationwide and Armenia, AUSTRIA, Bahrain, Belgium, CROATIA, CZECH REPUBLIC, Denmark, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, Hungary, Israel, ITALY, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, LITHUANIA, LUXEMBOURG, Macedonia, NETHERLANDS, Norway, POLAND, Qatar, Romania, SAUDI ARABIA, Serbia, Slovakia, SOUTH AFRICA, Spain, Sweden, SWITZERLAND, TAIWAN, Turkey, Ukraine, UNITED ARAB EMIRATES, and United Kingdom.
Derived failure modes
-
Unknown
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.