FDA Device recall Z-1887-2016
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only
- FDA Device
- Class I
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class I recall of HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only by Heartware, citing heartware Ventricular Assist System Battery Cell experiencing premature depletion.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1887-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-01-07 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Heartware |
| Distribution | US |
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
Heartware Ventricular Assist System Battery Cell experiencing premature depletion.
Identifiers
| code_info | Serial numbers ranging BAT000001 to BAT199999. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1887-2016%22
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