GORE VIABIL Biliary Endoprosthesis VSWVN1006Recalls & reported problems
W. L. Gore & Associates, Inc. · VIABIL SHORT WIRE BILIARY ENDO 10mmX6cmX200cm 8.5Fr · Class 2 · Implant
All models of GORE VIABIL Biliary Endoprosthesis (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132638864), received between Jan 30, 2025 and Jan 30, 2025 — classified as 1 malfunction.
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.
Reports received per month
Recalls naming this device
- Sep 3, 2026Open, Classified
The potential for the devices to be mislabeled with the incorrect length.
Z-0158-2027 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 30, 2025
STENT WAS INSERTED INTO SCOPE AND WOULD NOT DEPLOY. THERE IS A SPACE AT THE TIP OF DEPLOYER AND SHEATH WHICH MAY BE THE CAUSE OF THE DEFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21272682 ↗
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-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-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-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
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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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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