Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VS
The potential for the devices to be mislabeled with the incorrect length.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
The potential for the devices to be mislabeled with the incorrect length.
The recalled product
- Product
- 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…
- Manufacturer
- W L Gore & Associates, Inc.
- Category
- Medical Device — Devices
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Related recalls
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