Biliary Endoprosthesis Labeling Mismatch Risks Incorrect Device Placement
W.L. Gore's GORE VIABIL Short Wire Biliary Endoprosthesis may be mislabeled regarding drainage holes, risking extended procedures, infections, and unplanned device removal in 24 units distributed in Georgia.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves labeling mismatch of a high-risk biliary endoprosthesis where incorrect placement could cause serious complications including biliary infections. However, no illnesses or injuries have been reported, making this a theoretical risk-of-harm scenario that scores at most 3 (High) per the rubric.
Plain-English summary
The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding medical device designed to keep the common bile duct open when it becomes obstructed. Two versions are affected: Catalog Number VSWVH1008 (10 mm x 8 cm, with transmural drainage holes) and Catalog Number VSWVN1008 (10 mm x 8 cm, without holes). The device is delivered to the target site through a catheter-based system.
Some affected units may carry incorrect labeling—devices with transmural drainage holes may be labeled as lacking them, or devices without holes may be labeled as having them. This labeling error means a surgeon implanting the device may unknowingly place the wrong configuration.
If the incorrect device configuration is implanted, complications may include extended procedure time, unplanned device removal, the need for secondary procedures, infections of the bile duct (cholangitis) or gallbladder (cholecystitis), and pain. No illnesses or injuries have been reported in connection with this recall.
The affected units (24 total, specific serial numbers listed) were distributed nationwide in the state of Georgia. Healthcare providers should immediately verify the actual device configuration and drainage-hole status before implantation by checking the serial numbers and cross-referencing them with the provided UDI-DI and serial number lists.
The recalled product
- Product
- 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
- Manufacturer
- W.L. Gore & Associates, Inc.
- Affected units
- 24
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) UDI-DI 00733132638802
- Serial Numbers 27063943
- 27063944
- 27063949
- 27063950
- 27063952
- 27063953
- (2) UDI-DI 00733132638871
- Serial Numbers 27063379
- 27063380
- 27063381
- 27063382
- 27063383
- 27063384
- 27063385
- 27063386
- 27063387
- 27063426
- 27063427
- 27063428
Distribution
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