HeartWare Ventricular Assist System: HeartWare Battery — Class I medical device recall Z-1887-2016
Terminated recall by Heartware, Inc., reported 2016-07-20, distributed nationwide. Heartware Ventricular Assist System Battery Cell experiencing premature depletion.
| Recall number | Z-1887-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware, Inc., Miami Lakes, FL, United States |
| Recall initiated | 2016-01-07 |
| Classified | 2016-07-08 |
| Reported by FDA | 2016-07-20 |
| Terminated | 2020-03-27 |
| Distributed | Nationwide (US) |
| Model numbers | 1650 |
Product
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System is designed for in-hospital and out-of-hospital settings, including transportation via fixed-wing aircraft or helicopter.
Reason for recall
Heartware Ventricular Assist System Battery Cell experiencing premature depletion.
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-1887-2016. 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.