FDA Medical Device Recalls (openFDA)
W L Gore & Associates, Inc.: GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
- Recall number
- Z-2914-2026
- Recalling firm
- W L Gore & Associates, Inc.
- Product
- GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
- Status
- Open, Classified
- Initiated
- 2026-05-22
- Posted
- 2026-08-07
- Terminated
- not on file
- Reason
- 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
- Root cause
- Process control
- Action
- On 05/22/2026, an "URGENT MEDICAL DEVICE RECALL" Letter was sent via email to customers informing them that, 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010). Customers are instructed to: . Identify and return any unused devices within the scope of this recall for replacement. . Complete and sign the enclosed CUSTOMER RESPONSE / DEVICE RECONCILIATION FORM and return to Ashley.Mitch@Olympus.com within 2 weeks of receipt of this notification. . This notice needs to be shared with those who should be aware within your institution or to any organization where potentially affected devices have been transferred (as appropriate). . Implanting Physicians: If you have implanted one of the potentially mislabeled GORE VIABIL Short Wire Biliary Endoprosthesis devices, please be mindful of the potential health outcomes and plan to take the needed measures that could minimize any potential health hazards associated with this mislabeling. If a listed device has been used, please indicate the used device(s) on the CUSTOMER RESPONSE / DEVICE RECONCILIATION FORM and return to Ashley.Mitch@Olympus.com For questions or further assistance - contact Julie Skaife, Global Product Specialist & Brand Manager at juskaife@wlgore.com.
- Quantity
- 13 units
- Distribution
- U.S. Nationwide distribution in the states of GA and RI.
- Lot, serial or model codes
- Incorrect Catalogue Number/UDI: VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888; Lot Serial No. 30965053, 30965054, 30965055, 30965056, 30965057, 30965058, 30965059, 30965060, 30965061, 30965062, 30965063, 30965064, 30965065.
- 510(k) numbers
- ["K170740"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 2017233
- Firm city
- Flagstaff
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28