Instructions for Use — Class II medical device recall Z-1110-2022
Ongoing recall by Medtronic Inc, reported 2022-05-25, distributed nationwide. Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (E
| Recall number | Z-1110-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc, Minneapolis, MN, United States |
| Recall initiated | 2022-03-30 |
| Classified | 2022-05-17 |
| Reported by FDA | 2022-05-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, DE, DK, ES, FR, GB, GR, HU, IN, IT, JP, LU, NL, NO, NZ, PL, SK, TR, ZA |
| Quantity | 21,118 units |
| UPC / GTIN / UDI-DI | 00763000170967, 00888707002028, 00888707002639, 00888707003063, 00888707003070, 00888707003100, 00888707003117, 00888707003209, 00888707003254, 00888707003261, 00888707005364, 00888707005838, 00888707005968, 00888707006330, 00888707007139, 00888707007160 |
| Serial numbers | 1103, HW28725R01, HW28807R01, HW28848, HW28956, HW28961R01, HW28965, HW29011, HW29154, HW29163, HW29194, HW29199, HW29208R01, HW29209R01, HW29211, HW29212, HW29219, HW29221, HW29225R01, HW29226R01, HW29229, HW29241R01, HW29242R01, HW29245R01, HW29246 and 475 more |
| Model numbers | 1103, 1104, 1104JP, GR00526, IFU00358, IFU00375, IFU00376, IFU00520, IFU00526, IFU00593, IFU00614, M017475C001, MCS1705PU |
Product
Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are distributed with unique Catalog / Model Numbers: IFU00358, IFU00375, IFU00376, GR00526, IFU00520, IFU00526, IFU00593, IFU00614, M017475C001
Reason for recall
Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system.
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-1110-2022. 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.