GORE VIABIL Biliary Endoprosthesis VSWVN1004Recalls & reported problems
W. L. Gore & Associates, Inc. · VIABIL SHORT WIRE BILIARY ENDO 10mmX4cmX200cm 8.5Fr · Class 2 · Implant
All models of GORE VIABIL Biliary Endoprosthesis (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132638857), received between Apr 16, 2024 and Apr 30, 2024 — classified as 3 malfunctions.
4 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.
Reports received per month
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2024
STENT PARTIALLY DEPLOYED DURING OPENING, UNABLE TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19213094 ↗MalfunctionApr 30, 2024
ATTEMPTED TO DEPLOY STENT, PULLED STRING BUT STENT DID NOT DEPLOY OR OPEN AT ALL. COULD NOT USE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19213030 ↗MalfunctionApr 16, 2024
THE STENT WOULD NOT DEPLOY CORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19115030 ↗
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, ClassifiedGeneric Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis
- Z-2914-2026 · May 22, 2026 · Open, ClassifiedGORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may b
- Z-2915-2026 · May 22, 2026 · Open, ClassifiedGORE 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, ClassifiedGORE 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
Other Catheter, Biliary, Diagnostic devices
- Hurricane™ RX M00545900Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls1 death705 reports
- MUSTANG™ H74939171060470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC384 reports
- CRE™ PRO M00558710Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC1 recall284 reports
- Hurricane™ RX M00545920Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls211 reports
- MUSTANG™ H74939171070470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC265 reports
- MUSTANG™ H74939171050470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC212 reports
- Hurricane™ RX M00545940Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
- MUSTANG™ H74939171100470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC203 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page