GORE VIABIL Biliary Endoprosthesis VSWVN1010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132638888), received between May 7, 2026 and May 7, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K170740); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 22, 2026Class IIOpen, Classified

   10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).

   Z-2914-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2026Improper or Incorrect Procedure or Method; Wrong Label

  IT WAS REPORTED THAT A POTENTIAL MISLABELING INCIDENT MAY HAVE OCCURRED INVOLVING A GORE® VIABIL® SHORT WIRE BILIARY ENDOPROSTHESIS, INTENDED TO BE CATALOG NUMBER VSWVN1010 AND LABELED AS A 10 MM × 10 CM STENT. THE PROCEDURE ON (B)(6), 2026 WAS PERFORMED IN THE SETTING OF PRIOR BILIARY INTERVENTIONS. AT THE TIME OF THE PROCEDURE, A 10F × 9 CM PLASTIC BILIARY STENT (BOSTON SCIENTIFIC) AND AN EXISTING GORE® VIABIL® SHORT WIRE BILIARY ENDOPROSTHESIS MEASURING APPROXIMATELY 10 MM × 6 CM, WHICH HAD BEEN IMPLANTED APPROXIMATELY ONE TO TWO MONTHS PRIOR, WERE PRESENT IN THE BILE DUCT. THE EXISTING VIABIL STENT WAS REPORTED TO BE OCCLUDED. THE PROCEDURAL PLAN WAS TO REMOVE BOTH PREVIOUSLY IMPLANTED STENTS; HOWEVER, DUE TO ACCESS DIFFICULTY, THE PLASTIC STENT WAS REMOVED AND THE EXISTING VIABIL STENT WAS RELINED TO ADDRESS THE OCCLUSION BY PLACING A NEW VIABIL STENT THROUGH IT. DURING ADVANCEMENT AND DEPLOYMENT OF THE NEW VIABIL STENT ON (B)(6), 2026, THE DEVICE APPEARED SHORTER THAN EXPECTED UPON VISUAL INSPECTION. THIS CONCERN WAS RAISED INTRA-PROCEDURALLY BY AN EXPERIENCED ENDOSCOPY TECHNICIAN AND CONFIRMED BY THE IMPLANTING PHYSICIAN. REVIEW OF THE DEVICE PACKAGING DURING THE CASE INDICA

  Patient problems: Biliary Leak

  MAUDE report 25117235 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170740. One submission often covers many models, so check the product and lot details in each record.

• Z-0158-2027 · Sep 3, 2026 · Open, Classified
  Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis
• Z-2915-2026 · May 22, 2026 · Open, Classified
  GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may b
• Z-1179-2024 · Jan 19, 2024 · Open, Classified
  GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes