FDA Device recall Z-1698-2015
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205
- FDA Device
- Class I
- ongoing
- Published 2015-06-17
On 2015-06-17 the FDA classified a Class I recall of HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205 by Heartware, citing heartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1698-2015 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2015-04-29 |
| Published | 2015-06-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Heartware |
| Distribution | US |
Product
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
Reason
HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.
Identifiers
| code_info | Serial #: ALL HeartWare HVAD systems currently in use. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1698-2015%22
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