FDA Device recall Z-1917-2015
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refracto…
- FDA Device
- Class II
- ongoing
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refracto… by Heartware, citing complaints with the HVAD Abnormal Power Source Switching.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1917-2015 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2015-04-29 |
| Published | 2015-07-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Heartware |
| Distribution | AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA |
Product
HeartWare Ventricular Assist System (HVAD) 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
Complaints with the HVAD Abnormal Power Source Switching.
Identifiers
| code_info | Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. 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-1917-2015%22
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