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Boston Scientific Corporation Recall: HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscop

Boston Scientific Corporation Recall: HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscop is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Boston Scientific Corporation; Product: HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the

Recalling firmBoston Scientific Corporation
ProductHURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920
Reason for recallBalloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionUS Nationwide distribution.
Recall initiated20211021
Recall numberZ-0323-2022
Categorydevice
StateMA
CountryUnited States

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