FDA Device recall Z-0006-2017
HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103
- FDA Device
- Class I
- ongoing
- Published 2016-10-19
On 2016-10-19 the FDA classified a Class I recall of HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103 by Heartware, citing foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0006-2017 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2016-08-17 |
| Published | 2016-10-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Heartware |
| Distribution | AL, AR, AZ, CA, DC, FL, IL, IN, KY, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, WI |
Product
HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. 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. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Reason
Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.
Identifiers
| code_info | All sterile un-implanted stock manufactured prior to HW25838 is subject to removal. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0006-2017%22
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