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U.S. Department of Health and Human Services

Class 2 Device Recall PRO 2 Device

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 Class 2 Device Recall PRO 2 Devicesee related information
Date Initiated by FirmNovember 30, 2016
Create DateFebruary 08, 2017
Recall Status1 Terminated 3 on February 15, 2018
Recall NumberZ-1148-2017
Recall Event ID 76017
510(K)NumberK160454 
Product Classification Clip, implantable - Product Code FZP
ProductAtriClip" 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.
Code Information Model Numbers: PRO235, PRO240, PRO245, PRO250  Lot Numbers: 67102 to 68418
FEI Number 3011706110
Recalling Firm/
Manufacturer		 AtriCure, Inc.
7555 Innovation Way
Mason OH 45040-9695
For Additional Information ContactMr. Anupam K. Bedi
866-349-2342
Manufacturer Reason
for Recall		A complaint of the PRO2 jaw breaking prior to surgery being performed.
FDA Determined
Cause 2		Component design/selection
ActionRecall 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 Commerce464 units
DistributionDevices 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FZP
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