CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report
The Gore Viabil Short Wire Biliary Endoprosthesis recalled
W L Gore & Associates is recalling The Gore Viabil Short Wire Biliary Endoprosthesis is a flexible, self-expanding, distributed nationwide in the US. The recall was initiated on 3 Sep 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0158-2027
- FDA event ID
- 99873
- Recalling firm
- W L Gore & Associates, Flagstaff, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Sep 2026
- FDA classified
- 14 Oct 2026
- Reported
- 21 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 3 Sep 2026 | Recall initiated by company | |
| 14 Oct 2026 | Classified by FDA | +41 days |
| 21 Oct 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The potential for the devices to be mislabeled with the incorrect length.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of GA, RI.
Questions about this recall
Why was it recalled?
The potential for the devices to be mislabeled with the incorrect length.
Which lots are affected?
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;
Where was it sold?
US Nationwide distribution in the states of GA, RI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from W L Gore & Associates
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Gore Viabil Short Wire Biliary Endoprosthesis recalled | W L Gore & Associates | Labeling Errors | Nationwide |
| Device | CLASS II | Gore Viabil Short Wire Biliary Endoprosthesis recalled | W L Gore & Associates | Labeling Errors | Nationwide |
| Device | CLASS II | GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component recalled | W L Gore & Associates | Other | Nationwide |
| Device | CLASS II | Gore Acuseal Vascular Graft recalled by W L Gore & Associates | W L Gore & Associates | Packaging Defects | 51 states |
| Device | CLASS II | Heparin, Gore Viabahn VBX, Balloon Expandable recalled | W L Gore & Associates | Sterility | Nationwide |
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| Device | CLASS II | NaviFlex LW Pusher recalled by Boston Scientific | Boston Scientific | Other | Nationwide |
| Device | CLASS II | JenaValve Trilogy Delivery Catheter, Size recalled | Jenavalve Technology | Other | Nationwide |
| Device | CLASS II | Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack recalled | Sarnova HC | Other | Nationwide |
| Device | CLASS II | Medline surgical convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | JenaValve Trilogy Delivery Catheter, Size recalled | Jenavalve Technology | Other | Nationwide |