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GORE VIABIL Biliary Endoprosthesis
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MEDICAL DEVICE RECALLMODERATE

GORE VIABIL Biliary Endoprosthesis

GORE VIABIL biliary endoprosthesis recalled due to mislabeling of size and drainage holes.

What to do

If you have a GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010, check the device labeling to confirm the actual size and presence of transmural drainage holes. Contact W L Gore & Associates for instructions on returning or replacing the affected device.

Recalled
Listed
Updated
Recall No.
Z-2914-2026
Agency
FDA
Firm
W L Gore & Associates, Inc.
Recall ID
99143
Status
ONGOING

Recall at a glance

Quantity recalled
13 units

Why it was recalled

W L Gore & Associates is recalling the GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010, because some 10 mm x 7 cm devices with transmural drainage holes were incorrectly labeled as 10 mm x 10 cm devices without those holes. This mislabeling could lead to improper device selection and potential patient harm.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

GORE VIABIL Short Wire Biliary Endoprosthesis, Model No.

ProductLot codeRecall #UDI-DI
VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.30965053, 30965054, 30965055, 30965056, 30965057, 30965058, 30965059, 30965060, 30965061, 30965062, 30965063, 30965064, 30965065Z-2914-202600733132638888, 00733132638888, 00733132638888, 00733132638888, 00733132638888, 00733132638888, 00733132638888, 00733132638888, 00733132638888, 00733132638888, 00733132638888, 00733132638888, 00733132638888, 30965053, 30965054, 30965055, 30965056, 30965057, 30965058, 30965059
VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.30970948, 30970949, 30970950, 30970951, 30970952, 30970953, 30970954, 30970955, 30970956, 30970957, 30970958, 30970959, 30970960Z-2915-202600733132638796, 00733132638796, 00733132638796, 00733132638796, 00733132638796, 00733132638796, 00733132638796, 00733132638796, 00733132638796, 00733132638796, 00733132638796, 00733132638796, 00733132638796, 30970948, 30970949, 30970950, 30970951, 30970952, 30970953, 30970954

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Labeling Error recalls

Other recent recalls from W L Gore & Associates, Inc.

All recalls from W L Gore & Associates, Inc.

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Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification