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GORE VIABIL Biliary Endoprosthesis recallZ-0158-2027 · W L Gore & Associates, Inc. · initiated Sep 3, 2026

Open, Classified All recalls posted in October 2026

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 potential for the devices to be mislabeled with the incorrect length.

FDA root cause category: Under Investigation by firm

What the company is doing

On September 8, 2026, URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken by the customer/user: Identify and return any unused devices within the scope of this recall for replacement. Please acknowledge receipt of this letter according to the instructions provided by our distributor, Olympus. This notice needs to be shared with those who should be aware within your institution or to any organization where potentially affected devices have been transferred (as appropriate). Implanting Physicians: If you have implanted one of the potentially mislabeled GORE VIABIL Short Wire Biliary Endoprosthesis devices, please be mindful of the potential health outcomes and plan to take the needed measures that could minimize any potential health hazards associated with this mislabeling. If a listed device has been used, please indicate the device(s) used when you acknowledge receipt according to the enclosed instruction from our distributor, Olympus

Recall details

Recall number
Z-0158-2027
Recall class
Not yet classified by the FDA
Status
Open, Classified
Initiated by the company
Sep 3, 2026
Posted by the FDA
Oct 14, 2026
Recalling firm
W L Gore & Associates, Inc.
Quantity
32
Product code
FGE
FDA submissions
K170740
Distribution
US Nationwide distribution in the states of GA, RI.

Product description

Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. The endoprosthesis is radially compressed and secured onto the distal end of a catheter-based delivery system for deployment. The catheter provides a means for accessing and implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract.

Code information (models, lots, serial numbers)

1. Model/Catalog Number: VSWVH0808; UDI-DI: 00733132638772; Lot Serial Numbers: 30907025, 30907033, 30907034, 30907036, 30907023, 30907024, 30907026, 30907027, 30907028, 30907029 (complaint device), 30907030, 30907031, 30907032 (complaint device), 30907035, 30907037, 30907038; 2. Model/Catalog Number: VSWVN1006; UDI-DI: 00733132638864; Lot Serial Numbers: 30843556, 30843557, 30843558, 30843559, 30843560, 30843561, 30843562, 30843563, 30843564, 30843565, 30843566, 30843567, 30843568, 30843569, 30843570, 30843571;

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

6 devices cleared under K170740 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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