FDA Device recall Z-1209-2014
Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069
- FDA Device
- Class II
- terminated
- Published 2014-03-26
On 2014-03-26 the FDA classified a Class II recall of Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069 by Atricure, citing the firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1209-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-23 |
| Published | 2014-03-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Atricure |
| Distribution | US |
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.
Reason
The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
Identifiers
| code_info | Lot Number MFR-0424-1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1209-2014%22
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