medical Class II Updated 2021-12-08

Boston Scientific Corporation recalls HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatat

Recalled Product

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


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: GTIN: 08714729283805 Lot Numbers: 25612668, 25649812, 25704208, 25771760, 25878552, 26000695, 26010387, 26058284, 26087172, 26087173, 26123181, 26324742, 26366746, 26406513, 26429808, 26499853, 26527374, 26573853, 26638827, 26651718, 26665448, 26893604, 27026984, 27074109, 27145234, 27162321, 27255235, 27306699. Exp. 05/19/2022 to 05/13/2023
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