Heartware, Inc. Recall 88197
Description: HeartWare HVAD Pump Implant Kit, REF 1125
Heartware, Inc. Recall 88197 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2190-2021 |
| Event ID | 88197 |
| Event Description | HeartWare HVAD Pump Implant Kit, REF 1125 |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 4078 units |
| Recall 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. |
| Device Classification | 20210818 |
| Device Code Info | GTIN: 00888707000222, 00888707007641, 00888707005685 All serial numbers |
| Center Classification Date | 20210806 |
| Recall Initiation Date | 20210603 |
| Recalling Firm | Heartware, Inc. |
| Initial Notification | Letter |
| Similar To |