Reported Nov 16, 2016 · Terminated
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's…
AtriCure, 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: AtriCure, Inc. · 7555 Innovation Way · Mason, OH · 45040-9695
Is this the product you have?
- AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
- Lot codes and dates
- Model Numbers
PRO235PRO240
- PRO245 and PRO250 Lot Numbers65622 to 66773
- Model Numbers
- Amount recalled
- 298
Where it was sold
Why it was recalled
There is a potential for a component failure of the device which could necessitate medical intervention.
This product could cause temporary or reversible health problems — stop using it.
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