FDA Device recall Z-1471-2014
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205
- FDA Device
- Class I
- terminated
- Published 2014-04-30
On 2014-04-30 the FDA classified a Class I recall of Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205 by Heartware, citing the housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1471-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-12-06 |
| Published | 2014-04-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Heartware |
| Distribution | US |
Product
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Reason
The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector.
Identifiers
| code_info | Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. Serial Numbers: HW001 to HW11270 and HW20001 to HW 20296. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1471-2014%22
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