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U.S. Department of Health and Human Services

Class 2 Device Recall GORE TAG THORACIC ENDOPROSTHESIS

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  Class 2 Device Recall GORE TAG THORACIC ENDOPROSTHESIS see related information
Date Initiated by Firm April 28, 2006
Date Posted July 13, 2006
Recall Status1 Terminated 3 on December 13, 2006
Recall Number Z-1237-06
Recall Event ID 35507
PMA Number P040043 
Product Classification System, Endovascular Graft, Aortic Aneurysm Treatment - Product Code MIH
Product GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm
Code Information Lot numbers: 04150272, 04150273, 04150274, 04150275, 04150276, 04150277, 04150278, 04150279, 04150280, & 04150281
Recalling Firm/
Manufacturer		 W L Gore & Assoc, Inc.
1500 N. Fourth St
Flagstaff AZ 86001
For Additional Information Contact Timothy J. Rynn
928-864-3714
Manufacturer Reason
for Recall		 Two lots of uniquely different product were switched and mislabeled with the wrong length. 34mm x 10cm devices were mislabeled as 34mm x 15cm and vice versa.
FDA Determined
Cause 2		 Other
Action All the letters were sent via Federal Express to each Gore Field Sales Associate (FSA) to be hand-delivered to the Physician and to the hospital Risk Manager. A cover note to the FSA directing them regarding the hand delivery of the letter. Also included is a memo to the FSA with a document that the FSA is directed to complete, sign/date and return to Gore documenting hand-delivery of each of these letters. These letters were to be hand delivered on 18 May, or 19 May, 2006.
Quantity in Commerce 10
Distribution Nationwide to: AL, CT, KS, MA, & MN
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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