Recall Z-1209-2014
Atricure Inc · initiated January 23, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot Number MFR-0424-1
Reason for recall
The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
FDA-determined cause: Nonconforming Material/Component
Action taken
On 1/24/2014 the firm sent Urgent Recall Notification letters to their customers.
Details
- Recall number
- Z-1209-2014
- Initiated
- January 23, 2014
- Posted by FDA
- March 14, 2014
- Terminated
- May 13, 2014
- Product code
- HBT – Applier, Hemostatic Clip
- Quantity
- 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.
- Recalling firm
- Atricure Inc, West Chester, OH