Reported Apr 2, 2014 · Terminated
HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the…
Thoratec Corporation
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: Thoratec Corporation · 6035 Stoneridge Dr · Pleasanton, CA · 94588-3270
Is this the product you have?
- HeartMate
- II System Controller Product UsageHeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD. HeartMate II attaches to the heart and is designed to assist or take over the pumping function of the patients left ventricle, the main pumping chamber of the heart
- Lot codes and dates
- Catalog number 106762 (NAm) 106017 - EU all serial numbers
- Amount recalled
- 4120
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Stop using this product now
Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.
Using this product could cause serious injury, illness or death — stop using it now.
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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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