FDAFDA · Food and drugs·Recall number Z-1209-2014
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.
Published March 26, 2014 · Recall initiated: January 23, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Atricure Inc
- Distributor
- 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.
- Lot
- Lot Number MFR-0424-1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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