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Terminated

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.

FDA Recall Z-1209-2014 · Posted 2014-03-14

Recalling FirmAtricure Inc
Recall StatusTerminated
Product CodeHBT
Date Initiated2014-01-23
Date Terminated2014-05-13
Product Quantity46 units

Reason for Recall

The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.

Firm Action

On 1/24/2014 the firm sent Urgent Recall Notification letters to their customers.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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