Recall Z-1209-2014 ยท HBT Applier, Hemostatic Clip
Atricure Inc
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.
| Date | Mar 14, 2014 (initiated Jan 23, 2014) |
| Status | Terminated |
| Reason | The firm was notified by a customer of a cracked spring in the handle of the RCD1 device. |
| Root cause | Nonconforming Material/Component |
| Action | On 1/24/2014 the firm sent Urgent Recall Notification letters to their customers. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.