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Boston Scientific Corporation Recall 88991

Description: HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940

Boston Scientific Corporation Recall 88991 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0325-2022
Event ID88991
Event DescriptionHURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940
Product TypeDevices
DistributionUS Nationwide distribution.
Recall ReasonBalloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Device Classification20211208
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GTIN: 08714729283850 Exp. 05/18/2022 to 05/31/2023
Center Classification Date20211201
Recall Initiation Date20211021
Recalling FirmBoston Scientific Corporation
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