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Conformable Thoracic Stent Graft, Rx only, Sterile EO -… recallZ-2052-2020 · W L Gore & Associates, Inc. · initiated Dec 17, 2019

Class II Terminated All recalls posted in May 2020

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 & Associates, 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

The incorrect label was placed on both the primary and secondary package.

FDA root cause category: Labeling Change Control

What the company is doing

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

Recall details

Recall number
Z-2052-2020
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 17, 2019
Posted by the FDA
May 20, 2020
Recalling firm
W L Gore & Associates, Inc.
Quantity
15 stents
Product code
MIH
FDA submissions
P040043
Distribution
International the country of Japan.

Product description

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 (models, lots, serial numbers)

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

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.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page