HeartWare Ventricular Assist Device — Class I medical device recall Z-1512-2022
Ongoing recall by Heartware, Inc., reported 2022-08-24, distributed nationwide. Battery performance issues. Battery electrical faults render it unable to power the controller, unable to acce
| Recall number | Z-1512-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware, Inc., Miami Lakes, FL, United States |
| Recall initiated | 2022-06-28 |
| Classified | 2022-08-18 |
| Reported by FDA | 2022-08-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, BR, CA, CH, CL, CO, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IL, IN, IT, JP, KR, KW, LB, LU, LV, MY, NL, NO, NZ, PK, PL, QA, RS, SA, SE, SG, SK, TR, TW, UA, ZA |
| Quantity | 19,616 batteries |
| UPC / GTIN / UDI-DI | 00763000187767, 00888707005692, 00888707005708, 00888707006873, 00888707006897, 00888707008778, 00888707009942 |
| Serial numbers | 07429, 2511, 3152, 35232, 61564, 6866, 722, AT857749, AT943009, AT960247, BAT650004, BAT650005, BAT650014, BAT650018, BAT650020, BAT650021, BAT650022, BAT650026, BAT650027, BAT650031, BAT650032, BAT650033, BAT650034, BAT650035, BAT650036 and 475 more |
Product
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Reason for recall
Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging.
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-1512-2022. 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.