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.
USGORE 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.
Recalling Firm: W L Gore & Associates, Inc.
Reason for Recall / Hazard
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).
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Flagstaff |
| State | AZ |
| Event id | 99143 |
| Address 1 | 1505 N 4th St |
| Code info | 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. |
| Postal code | 86004-5867 |
| Report date | 20260819 |
| Product type | Devices |
| Product quantity | 13 units |
| Reason for recall | 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). |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260522 |
| Initial firm notification | |
| Center classification date | 20260807 |
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Overview
- Recalling FirmW L Gore & Associates, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide distribution in the states of GA and RI.
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🚨 SAFETY ALERT: 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. Check if your household is affected: https://therecallfile.com/recalls/gore-viabil-short-wire-biliary-endoprosthesis-model-no-vswvn1010-flexi/FDA-Z-2914-2026
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