FDA Device recall Z-1131-2015
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who ar…
- FDA Device
- Class I
- terminated
- Published 2015-03-04
On 2015-03-04 the FDA classified a Class I recall of HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who ar… by Heartware, citing the affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1131-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-01-16 |
| Published | 2015-03-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Heartware |
| Distribution | US |
Product
HeartWare Ventricular Assist System (HeartWare 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 HeartWare System is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Reason
The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.
Identifiers
| code_info | Product Codes- US product: Model No.: 1400, 1401US; International product: Model No.: 1400, 1401XX ('XX' represents cou…Product Codes- US product: Model No.: 1400, 1401US; International product: Model No.: 1400, 1401XX ('XX' represents country designation) Serial No.: CON000001 through CON005472 |
|---|
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-1131-2015%22
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