Recall Z-1209-2014— Atricure Inc
Class II · Terminated
Class II FDA medical device recall by Atricure Inc, initiated 2014-01-23, terminated 2014-05-13. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The firm was notified by a customer of a cracked spring in the handle of the RCD1 device..
- Recalling firm
- Atricure Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-01-23
- Terminated
- 2014-05-13
- Firm location
- West Chester, OH, United States
Product description
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.
Reason for recall
The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.