medical Class II Updated 2021-12-08

Boston Scientific Corporation recalls HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilata

Recalled Product

HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930

Hazard / Issue

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Batches: 25644951, 25649190, 25650286, 25651334, 25654287, 25947916, 25947918, 26010397, 26058298, 26406532, 26435581, 26449368, 26533973, 26555544, 26868194, 27074110, 27269956, 27384708. GTIN: 08714729283843 Exp. 05/27/2022 to 05/26/2023
View official government recall

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