FDA Medical Device Recalls (openFDA)
AtriCure, Inc.: 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.
- Recall number
- Z-0377-2017
- 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.
- Status
- Terminated
- Initiated
- 2016-09-22
- Posted
- not on file
- Terminated
- 2018-02-15
- Reason
- There is a potential for a component failure of the device which could necessitate medical intervention.
- 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
- 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
- Lot, serial or model codes
- Model Numbers: PRO235, PRO240, PRO245 and PRO250 Lot Numbers: 65622 to 66773
- 510(k) numbers
- ["K160454"]
- PMA numbers
- not on file
- Product code
- FZP
- Firm FEI
- 3011706110
- Firm city
- Mason
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28