W L Gore VIABIL Short Wire Biliary Endoprosthesis VSWVN1010 Recall
The recall involves the GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010, with 13 units distributed nationwide in GA and RI. The devices were mislabeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010) when they are 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006). The affected lot serial numbers are 30970948 through 30970960. No corrective action is listed.
| Brand | W L Gore & Associates, Inc. |
|---|---|
| Product | GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. |
| 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). |
| Severity | moderate |
| Units affected | 13 |
| Distribution | U.S. Nationwide distribution in the states of GA and RI. |
| Agency | FDA |
WHAT YOU SHOULD DO
- If you have any GORE VIABIL Short Wire Biliary Endoprosthesis from lots 30970948–30970960, stop using them and consult your healthcare provider.
- Do not implant or use devices labeled as VSWVN1010 until advised; verify model and lot numbers with your clinician.
- Contact the manufacturer (GORE) or the hospital/distributor for disposition, replacement, or further instructions.
- If you have health concerns, seek medical advice promptly.
How to identify the recalled item
| Lot / date codes | Incorrect Catalogue Number/UDI: VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796; Lot Serial No. 30970948, 30970949, 30970950, 30970951, 30970952, 30970953, 30970954, 30970955, 30970956, 30970957, 30970958, 30970959, 30970960. |
|---|---|
| Lot / date 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. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other W L Gore & Associates, Inc. recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.