Medtronic HVAD Pump Implant Kits — Class I medical device recall Z-0946-2021
Ongoing recall by Heartware, Inc., reported 2021-02-10, distributed nationwide. Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start,
| Recall number | Z-0946-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware, Inc., Miami Lakes, FL, United States |
| Recall initiated | 2020-11-19 |
| Classified | 2021-02-04 |
| Reported by FDA | 2021-02-10 |
| Distributed | Nationwide (US) |
| Quantity | 19,562 units |
| UPC / GTIN / UDI-DI | 00763000170967, 00888707000017, 00888707000239, 00888707000581, 00888707000604, 00888707000611, 00888707000628, 00888707000635, 00888707000642, 00888707000666, 00888707000680, 00888707000697, 00888707001434, 00888707001649, 00888707002028, 00888707002141, 00888707002264, 00888707002387, 00888707002394, 00888707002400, 00888707002417, 00888707002424, 00888707002431, 00888707002448, 00888707002455 and 51 more |
| Serial numbers | 1104, HW001, HW012, HW016, HW017, HW023, HW025, HW028, HW044, HW045, HW046, HW047, HW049, HW050, HW051, HW061, HW064, HW083, HW084, HW086, HW091, HW094, HW1000, HW10001, HW10002 and 475 more |
| Model numbers | 1100, 1101, 1102, 1103, 1104, 1104CA-CLIN, 1104JP, 1205, MCS1705PU |
Product
Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU
Reason for recall
Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall population.
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-0946-2021. 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.