FDA Device recall Z-0005-2017
HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of…
- FDA Device
- Class I
- terminated
- Published 2016-10-26
On 2016-10-26 the FDA classified a Class I recall of HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of… by Heartware, citing loose connector ports in controller body.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0005-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-06-08 |
| Published | 2016-10-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Heartware |
| Distribution | US |
Product
HeartWare Ventricular Assist System Controller Product Usage: 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 HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
Reason
Loose connector ports in controller body.
Identifiers
| code_info | All Heartware Controllers manufactured after September 2014. US Model No: 1400, 1401XX, 1403US. International Model No: 1400, 1401XX, 1407XX. |
|---|
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-0005-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.