Z-1209-2014Class II

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

Name: Z-1209-2014 Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The...
Creator: Atricure Inc
Published: 2014-01-23
License: https://open.fda.gov/license/

AtriCure, Inc. / initiated 2014-01-23 / Terminated / root cause: manufacturing process

FDA source

Atricure Inc began a recall of Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be... on 2014-01-23. FDA classified it as Class II and gives the reason as "The firm was notified by a customer of a cracked spring in the handle of the RCD1 device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1209-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-23
Posted: 2014-03-14
Terminated: 2014-05-13
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.
Product code: HBT Applier, Hemostatic Clip
Reason for recall: The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 1/24/2014 the firm sent Urgent Recall Notification letters to their customers.
Quantity in commerce: 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.
Product codes and lots: Lot Number MFR-0424-1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1209-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1209-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-14

Product code HBT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)