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.
FDA Recall Z-1148-2017 · Posted None
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Recalling FirmAtriCure, Inc.
Recall StatusTerminated
Product CodeFZP
Date Initiated2016-11-30
Date Terminated2018-02-15
Product Quantity464 units
Reason for Recall
A complaint of the PRO2 jaw breaking prior to surgery being performed.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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