HeartWare Ventricular Assist Device — Class II medical device recall Z-0726-2022
Ongoing recall by Heartware, Inc., reported 2022-03-16, distributed nationwide. Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to pro
| Recall number | Z-0726-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware, Inc., Miami Lakes, FL, United States |
| Recall initiated | 2022-01-27 |
| Classified | 2022-03-04 |
| Reported by FDA | 2022-03-16 |
| 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, PK, PL, QA, RO, RS, SA, SE, SG, SK, TR, TW, UA, VN, ZA |
| Quantity | 197,889 units |
| Model numbers | 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT and 24 more |
Product
HeartWare Ventricular Assist Device (HVAD) System
Reason for recall
Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins as a mitigation for power switching.
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-0726-2022. 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.