HeartWare HVAD Pump Implant Kit — Class I medical device recall Z-2190-2021
Ongoing recall by Heartware, Inc., reported 2021-08-18, distributed nationwide. Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clin
| Recall number | Z-2190-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware, Inc., Miami Lakes, FL, United States |
| Recall initiated | 2021-06-03 |
| Classified | 2021-08-06 |
| Reported by FDA | 2021-08-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BH, CH, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HR, HU, IL, IT, JO, KW, LB, LT, LU, LV, NL, NO, PL, QA, RO, RS, SA, SE, SK, TR, TW, UA, ZA |
| Quantity | 4,078 units |
| UPC / GTIN / UDI-DI | 00888707000222, 00888707005685, 00888707007641 |
| Model numbers | 1125 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2190-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.