Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0077-2022 — Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:

U.S. FDA — Device Enforcement · United States · 2021-09-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0077-2022
Date of alert: 2021-09-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: W L Gore & Associates, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 22753580

Reported risk: Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-0077-2022 — Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:

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