FDA Device recall Z-1726-2015
HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 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 #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205 by Heartware, citing complaints with the HVAD Retraction of Pins within the driveline connector.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1726-2015 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2015-04-29 |
| Published | 2015-06-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Heartware |
| Distribution | 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). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.
Reason
Complaints with the HVAD Retraction of Pins within the driveline connector.
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-1726-2015%22
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