AtriClip LAA Exclusion System with preloaded recall
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under…
Why was AtriClip LAA Exclusion System with preloaded recalled?
There is a potential for a component failure of the device which could necessitate medical intervention.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Numbers: PRO235, PRO240, PRO245 and PRO250 Lot Numbers: 65622 to 66773
- Product
- AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under…
- Recalling firm
- AtriCure, Inc.
- Quantity
- 298
- Distribution
- Nationwide Distribution to the follwoing states: AL, AR, AZ, CA, CT, FL, GA, IL, KS, MD, MI, MN, MO, MS, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT & WI. Product was also shipped to the following countries: Poland and Switzerland
- Recall date
- November 16, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)