RecallRadar

FDA Device recall Z-1209-2014

Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069

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

AgencyFDA Device
Recall numberZ-1209-2014
ClassificationClass II
Statusterminated
Initiated2014-01-23
Published2014-03-26
Last updated2026-09-13 11:53 UTC
CompanyAtricure
DistributionUS

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_infoLot 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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