HeartWare Model 1101 — Class II medical device recall Z-0743-2023
Ongoing recall by Heartware, Inc., reported 2022-12-28. Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover bac
| Recall number | Z-0743-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware, Inc., Miami Lakes, FL, United States |
| Recall initiated | 2022-11-29 |
| Classified | 2022-12-21 |
| Reported by FDA | 2022-12-28 |
| Quantity | 82 units |
| Serial numbers | HW107, HW1091, HW1143, HW1144, HW1146, HW1200, HW1205, HW1209, HW1242, HW1243, HW1244, HW1247, HW1276, HW1280, HW1398, HW1403, HW1415, HW1437, HW1439, HW1454, HW1456, HW1524, HW1533, HW1553, HW1555 and 57 more |
| Model numbers | 1101 |
Product
HeartWare Model 1101
Reason for recall
Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
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-0743-2023. 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.