FDA Device recall Z-1813-2013
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
- FDA Device
- Class II
- terminated
- Published 2013-08-07
On 2013-08-07 the FDA classified a Class II recall of Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) by Heartware, citing potential to electrostatic discharged (ESD).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1813-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-16 |
| Published | 2013-08-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Heartware |
| Distribution | AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI |
Product
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Reason
Potential to electrostatic discharged (ESD)
Identifiers
| code_info | US product: Model 1400, 1401US, 1403US, 1404 International: Model 1400, 1401XX, 1407XX, 1408 ALL HEARTWARE CONTROLLER SERIAL NUMBERS |
|---|
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-1813-2013%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.