Device product
Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial appendage.
Z-1209-2014
Product summary
- Firm
- Atricure Inc
- Event
- Event 67572
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46 units
- Official record key
device-enforcement:Z-1209-2014
Official wording
Reason: The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
Code information: Lot Number MFR-0424-1
Distribution pattern: Nationwide Distribution-including the states of AL, CA, CO, CT, DE, FL, KY, MD, MI, MN, MO, NC, NY, OH, OR, PA, TN, UT, VA & WA.
Derived failure modes
-
Unknown
The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.