Heartware HVAD Pump Implant Kit — Class I medical device recall Z-2056-2020
Ongoing recall by Heartware, Inc., reported 2020-06-03. The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump as
| Recall number | Z-2056-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware, Inc., Miami Lakes, FL, United States |
| Recall initiated | 2020-04-03 |
| Classified | 2020-05-22 |
| Reported by FDA | 2020-06-03 |
| Quantity | 2,225 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00888707000239, 00888707000581, 00888707000680, 00888707001649, 00888707002028, 00888707002141, 00888707002264, 00888707002387, 00888707002394, 00888707002400, 00888707002417, 00888707002424, 00888707002431, 00888707002448, 00888707002455, 00888707002462, 00888707002486, 00888707002493, 00888707002516, 00888707002523, 00888707002530, 00888707002547, 00888707002554, 00888707002585, 00888707004558 and 13 more |
| Serial numbers | HW26099, HW26126, HW26330, HW26660, HW26939, HW26940, HW27099, HW27452, HW27678, HW28063, HW28199, HW28373, HW28418, HW28848, HW28851, HW28895, HW28973, HW29011, HW29073, HW29132, HW29154, HW29203, HW29211, HW29214, HW29232 and 475 more |
| Model numbers | 1104 |
Product
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
Reason for recall
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
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-2056-2020. 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.