Z-0377-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 16, 2016
- Initiation Date
- September 22, 2016
- Termination Date
- February 15, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 298
Product Description
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.
Reason for Recall
There is a potential for a component failure of the device which could necessitate medical intervention.
Distribution Pattern
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
Code Information
Model Numbers: PRO235, PRO240, PRO245 and PRO250 Lot Numbers: 65622 to 66773