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

Recall Z-0320-2022 — HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890

U.S. FDA — Device Enforcement · United States · 2021-10-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0320-2022
Date of alert
2021-10-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
08714729283805
Reported risk: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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