Heartware, Inc. Recall: HeartWare HVAD Pump Implant Kit, REF 1125
Heartware, Inc. Recall: HeartWare HVAD Pump Implant Kit, REF 1125 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Heartware, Inc.; Product: HeartWare HVAD Pump Implant Kit, REF 1125; Reason for recall: Medtronic is stopping the distribution and sale of the HVAD System due to a growing
| Recalling firm | Heartware, Inc. |
|---|---|
| Product | HeartWare HVAD Pump Implant Kit, REF 1125 |
| 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. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Ongoing |
| 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, |
| Recall initiated | 20210603 |
| Recall number | Z-2190-2021 |
| Category | device |
| State | FL |
| Country | United States |
$29/mo
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