HeartWare HVAD Pump Implant Kit — Class I medical device recall Z-1207-2022
Ongoing recall by Medtronic Inc, reported 2022-06-15, distributed nationwide. The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by
| Recall number | Z-1207-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc, Minneapolis, MN, United States |
| Recall initiated | 2022-04-14 |
| Classified | 2022-06-03 |
| Reported by FDA | 2022-06-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, JP |
| Quantity | 21 pump |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00763000170967, 00888707003070, 00888707005364, 00888707007139, 00888707009041 |
| Serial numbers | HW41784, HW41825, HW41829, HW41849, HW41852, HW41853, HW41863, HW42153, HW42312, HW42352, HW42448, HW42571, HW42775, HW42818, HW42879, HW42882, HW42884, HW42955, HW42962, HW43483, HW43484 |
| Model numbers | 1104JP, MCS1705PU |
Product
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Reason for recall
The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld defect on the center post cap may allow moisture into the center post and corrode the magnets that keep the impeller rotating concentrically, leading to unintended contact between the center post and impeller. If this occurs, it may affect blood flow through the pump. The issue may present clinical signs and symptoms that resemble pump thrombosis.
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-1207-2022. 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.