FDA Device recall Z-1323-2013
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
- FDA Device
- Class II
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class II recall of Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) by Heartware, citing heartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1323-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-27 |
| Published | 2013-05-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Heartware |
| Distribution | US |
Product
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Reason
HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.
Identifiers
| code_info | Serial Numbers: United States: HW001-HW3827 and International: HW001-HW3827 and HW1000-HW10675 |
|---|
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-1323-2013%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.