Medtronic HVAD Pump Implant Kits — Class II medical device recall Z-2478-2021
Ongoing recall by Heartware, Inc., reported 2021-09-22, distributed nationwide. There is more force required to slide the driveline cover (boot cover) away from the connector after completio
| Recall number | Z-2478-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware, Inc., Miami Lakes, FL, United States |
| Recall initiated | 2021-08-06 |
| Classified | 2021-09-16 |
| Reported by FDA | 2021-09-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CO, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IL, IN, IT, JP, KR, KW, LB, LT, LU, LV, MY, NL, NO, NZ, PL, RO, RS, SA, SE, SG, SK, TR, TW, UA, VN, ZA |
Product
Medtronic HVAD Pump Implant Kits
Reason for recall
There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair than over an unrepaired strain relief. This may lead to difficulty in pulling back the driveline cover when attempting to access the Driveline connector during a controller exchange. Additionally, sliding the driveline cover over a strain relief repair may compromise the repair.
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-2478-2021. 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.