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GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular… recallZ-1237-06 · W L Gore & Assoc, Inc. · initiated Apr 28, 2006

Terminated All recalls posted in July 2006

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from W L Gore & Assoc, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-1237-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 28, 2006
Posted by the FDA
Jul 13, 2006
Recalling firm
W L Gore & Assoc, Inc.
Quantity
10
Product code
MIH
FDA submissions
P040043
Distribution
Nationwide to: AL, CT, KS, MA, & MN

Product description

GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm

Code information (models, lots, serial numbers)

Lot numbers: 04150272, 04150273, 04150274, 04150275, 04150276, 04150277, 04150278, 04150279, 04150280, & 04150281

Other devices under the same FDA submission

54 devices cleared under P040043 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 35507).

Sources and updates

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