HeartWare HVAD System Battery Charger The HeartWare HVAD System is… — Class I medical device recall Z-1427-2020
Ongoing recall by Heartware, Inc., reported 2020-03-18. Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller
| Recall number | Z-1427-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware, Inc., Miami Lakes, FL, United States |
| Recall initiated | 2020-01-23 |
| Classified | 2020-03-09 |
| Reported by FDA | 2020-03-18 |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, HR, IL, IN, IT, JP, KR, KW, LB, LT, LU, LV, MY, NL, NO, NZ, PL, RO, RS, SA, SE, SG, SK, TR, TW, VN, ZA |
| Quantity | 5,489 devices |
| UPC / GTIN / UDI-DI | 00888707000536, 00888707001144, 00888707001151, 00888707001168, 00888707001175, 00888707001182, 00888707001199, 00888707001205, 00888707001212, 00888707001229, 00888707001236, 00888707001564, 00888707002165, 00888707002189, 00888707002196, 00888707002202, 00888707002219, 00888707002226, 00888707002233, 00888707002240, 00888707002257, 00888707002967, 00888707002974, 00888707002981, 00888707002998 and 9 more |
| Model numbers | 1610 |
Product
HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
Reason for recall
Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
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-1427-2020. 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.