W L Gore & Associates, Inc.: GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal pat
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / 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 / 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).
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- U.S. Nationwide distribution in the states of GA and RI.
- Recall initiated
- 2026-05-22
- Code info
- 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.
- Product quantity
- 13 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Flagstaff
- State
- AZ
- Country
- United States
- Event id
- 99143
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