Z-1148-2017Class II

AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a...

Name: Z-1148-2017 AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a...
Creator: AtriCure, Inc.
Published: 2016-11-30
License: https://open.fda.gov/license/

AtriCure, Inc. / initiated 2016-11-30 / Terminated / root cause: design

FDA source

AtriCure, Inc. began a recall of AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed polyethylene... on 2016-11-30. FDA classified it as Class II and gives the reason as "A complaint of the PRO2 jaw breaking prior to surgery being performed". 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-1148-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-30
Posted: 2017-02-08
Terminated: 2018-02-15
Recalling firm: AtriCure, Inc.
Product: AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed polyethylene terephthalate glycol (PETG) tray with a Tyvek lid. A single-walled non-corrugated box completes the single unit package. Six (6) single unit PRO2 devices are packaged into one (1) corrugate shipper box.
Product code: FZP Clip, Implantable
Reason for recall: A complaint of the PRO2 jaw breaking prior to surgery being performed.
Root cause tag: design
FDA root cause: Component design/selection
Action: Recall notification letters were mailed to all Atricure customers. Email notification letters were forwarded to all Atricure field-based personnel, who may also conduct in-person meetings. Telephone calls will be made as needed and effectiveness checks will be conducted.
Quantity in commerce: 464 units
Distribution: Devices were distributed in the following states: AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NE, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, & WI. Devices were distributed in the following countries: Austria, Germany, Netherlands, Poland, Sweden, Switzerland and United Kingdom.
Product codes and lots: Model Numbers: PRO235, PRO240, PRO245, PRO250 Lot Numbers: 67102 to 68418

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1148-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1148-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-15	2017-02-07

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)