FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1209-2014
- Recalling firm
- Atricure Inc
- 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.
- Status
- Terminated
- Initiated
- 2014-01-23
- Posted
- 2014-03-14
- Terminated
- 2014-05-13
- 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.
- Lot, serial or model codes
- Lot Number MFR-0424-1
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HBT
- Firm FEI
- 3011706110
- Firm city
- West Chester
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28