Reported May 22, 2013 · Terminated
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Heartware Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 · 14000 NW 57th Ct · Miami Lakes, FL · 33014-3105
Is this the product you have?
- Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
- Lot codes and dates
- Serial NumbersUnited
- StatesHW001-HW3827
- and InternationalHW001-HW3827 and HW1000-HW10675
- Amount recalled
- 3,544
Where it was sold
Why it was recalled
HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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