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Atricure Inc recalls Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Cl
Recalled March 26, 2014 · FDA recall Z-1209-2014 · Atricure
Hazard
The firm was notified by a customer of a cracked spring in the handle of the RCD1 device. · FDA Class II
Units
46 units
Sold at
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.
Description
The firm was notified by a customer of a cracked spring in the handle of the RCD1 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.
Manufacturer(s)
Atricure Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →