Reported Apr 30, 2014 · Terminated
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104,…
HeartWare Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: HeartWare Inc · 14400 Nw 60th Ave · Miami Lakes, FL · 33014-2807
Is this the product you have?
- Heartware HVAD Pump Implant Kit (Heartware Ventricular
- Assist Device) Catalog Numbers1100, 1101, 1102, 1103, 1104, and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
- Lot codes and dates
- Catalog Numbers
11001101110211031104and 1205
- Serial NumbersHW001 to HW11270 and HW20001 to HW 20296
- Catalog Numbers
- Amount recalled
- 4,586
Where it was sold
Why it was recalled
Stop using this product now
The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new HeartWare Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.