HeartWare — Class II medical device recall Z-2072-2021
Ongoing recall by Heartware, Inc., reported 2021-07-21. The pump has an impeller with a shroud height that did not meet the lower control limit.
| Recall number | Z-2072-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware, Inc., Miami Lakes, FL, United States |
| Recall initiated | 2021-05-28 |
| Classified | 2021-07-13 |
| Reported by FDA | 2021-07-21 |
| Countries outside the US | DE |
| Quantity | 1 units |
| UPC / GTIN / UDI-DI | 00888707007139 |
| Serial numbers | HW42843 |
| Model numbers | MCS1705PU |
Product
HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
Reason for recall
The pump has an impeller with a shroud height that did not meet the lower control limit.
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-2072-2021. 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.