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.
Reported: March 26, 2014 Initiated: January 23, 2014 #Z-1209-2014
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.
Details
- Recalling Firm
- Atricure Inc
- Units Affected
- 46 units
- Distribution
- 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.
- Location
- West Chester, OH
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Atricure Inc. Units affected: 46 units.
Why was this product recalled? ▼
The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 26, 2014. Severity: Moderate. Recall number: Z-1209-2014.
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