Heartware HVAD Pump Implant Kit — Class I medical device recall Z-1471-2014
Terminated recall by HeartWare Inc, reported 2014-04-30, distributed nationwide. The housing to the Pump's driveline connector became partially or fully separated from the front portion of th
| Recall number | Z-1471-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | HeartWare Inc, Miami Lakes, FL, United States |
| Recall initiated | 2013-12-06 |
| Classified | 2014-04-22 |
| Reported by FDA | 2014-04-30 |
| Terminated | 2016-11-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CL, CZ, DE, ES, FR, GB, GR, HK, HR, IL, IN, IT, JP, LB, LT, LU, MY, NL, NO, NZ, PL, SG, SK, TR, ZA |
| Quantity | 4,586 |
| Serial numbers | 20296, HW001, HW11270, HW20001 |
| Model numbers | 1100, 1101, 1102, 1103, 1104, 1205 |
Product
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Reason for recall
The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector.
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-1471-2014. 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.