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Boston Scientific Corporation recalls HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of O
Recalled December 8, 2021 · FDA recall Z-0322-2022 · Boston Scientific
Hazard
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure · FDA Class II
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US Nationwide distribution.
Description
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Product
HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →