Z-0377-2017Class II

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the...

Name: Z-0377-2017 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the...
Creator: AtriCure, Inc.
Published: 2016-09-22
License: https://open.fda.gov/license/

AtriCure, Inc. / initiated 2016-09-22 / Terminated / root cause: design

FDA source

AtriCure, Inc. began a recall of AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct... on 2016-09-22. FDA classified it as Class II and gives the reason as "There is a potential for a component failure of the device which could necessitate medical intervention". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0377-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-22
Posted: 2016-11-09
Terminated: 2018-02-15
Recalling firm: AtriCure, Inc.
Product: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Product code: FZP Clip, Implantable
Reason for recall: There is a potential for a component failure of the device which could necessitate medical intervention.
Root cause tag: design
FDA root cause: Device Design
Action: AtriCure sent an Urgent Advisory Notice dated September 21, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and determine if they have any affected product. If so customers should ensure that all users of the affected devices are aware of the Advisory Notice. If customers further distributed the product, they should identify their customers and notify them at once of the Advisory Notice. Any units from the affected lots should be returned to AtriCure, Inc. Customers should contact AtriCure customer service at 1-866-349-2342, and select option 6 to return any affected product(s). Customers were asked to complete and return the enclosed Device Notification Acknowledgement Form as soon as possible. Customers with questions should call 513-755-4563.
Quantity in commerce: 298
Distribution: Nationwide Distribution to the follwoing states: AL, AR, AZ, CA, CT, FL, GA, IL, KS, MD, MI, MN, MO, MS, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT & WI. Product was also shipped to the following countries: Poland and Switzerland
Product codes and lots: Model Numbers: PRO235, PRO240, PRO245 and PRO250 Lot Numbers: 65622 to 66773

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0377-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0377-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-16	2016-11-09

Product code FZP

K160454Class IIAtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc. / cleared 2016-03-18

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)