FDA Device recall Z-1751-2015
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 2015-06-17
On 2015-06-17 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 Discolored and Cracked Driveline Outer Sheath.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1751-2015 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2015-04-29 |
| Published | 2015-06-17 |
| 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 Discolored and Cracked Driveline Outer Sheath.
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-1751-2015%22
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