Reported Apr 2, 2014 · Terminated
Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mechanical device that…
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?
- Heart Mate II Pocket Controllers
- removed from packaging 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
- Lot codes and dates
- Catalog number 105109 (found on side of unit) all serial numbers
- Amount recalled
- 7436 in total
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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