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U.S. Department of Health and Human Services

Class 2 Device Recall GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

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  Class 2 Device Recall GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System see related information
Date Initiated by Firm December 17, 2019
Date Posted May 20, 2020
Recall Status1 Terminated 3 on April 28, 2021
Recall Number Z-2052-2020
Recall Event ID 85434
PMA Number P040043 
Product Classification System, endovascular graft, aortic aneurysm treatment - Product Code MIH
Product Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
Code Information Part number of the device is TGM343420J Serial numbers: 21225065 21225066 21225067 21225068 21225069 21225070 21225071 21225072 21225073 21225074 21225075 21225076 21225077 21225078 21225079 21225080 21225081 21225082 21225083 21225084   
Recalling Firm/
Manufacturer		 W L Gore & Associates, Inc.
1500 N 4th St
Flagstaff AZ 86004-5866
For Additional Information Contact Miyuki Kurihara
928-864-2262
Manufacturer Reason
for Recall		 The incorrect label was placed on both the primary and secondary package.
FDA Determined
Cause 2		 Labeling Change Control
Action On 12/17/2019, the firm's field representatives hand delivered an URGENT MEDICAL DEVICE RECALL Notification to customers informing them of a label issue with their stents. Two (2) of the 20 units in their work order are labeled with the incorrect part number and size on both the package and carton labels. Customers are instructed to: return the affected products for replacement and If customers have any questions or concern to contact Field Sales Associates for assistance at Telephone number: 03-6746-2560, FAX number: 03-6746-2561
Quantity in Commerce 15 stents
Distribution International the country of Japan.
Total Product Life Cycle TPLC 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.
PMA Database PMAs with Product Code = MIH and Original Applicant = W. L. GORE & ASSOCIATES, INC.
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