PUMP 1103 HVAD — Class II medical device recall Z-0478-2024
Ongoing recall by Heartware, Inc., reported 2023-12-13. Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates
| Recall number | Z-0478-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware, Inc., Miami Lakes, FL, United States |
| Recall initiated | 2023-10-31 |
| Classified | 2023-12-01 |
| Reported by FDA | 2023-12-13 |
| Quantity | 7,438 units |
| UPC / GTIN / UDI-DI | 00888707002639, 00888707003261 |
| Serial numbers | 1008, HW10991, HW11011, HW11012, HW11013, HW11017, HW11019, HW11020, HW11022, HW11023, HW11024, HW11026, HW11030, HW11032, HW11033, HW11034, HW11035, HW11036, HW11037, HW11038, HW11040, HW11042, HW11043, HW11044, HW11046 and 475 more |
| Model numbers | 1103 |
Product
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
Reason for recall
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
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-0478-2024. 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.