medical Class II Updated 2021-12-08

Boston Scientific Corporation recalls HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatat

Recalled Product

HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910

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: 8714729283829 Batches: 25623385, 25678822, 25739151, 25771772, 25975774, 26010392, 26051928, 26087733, 26123186, 26175469, 26406521, 26429810, 26456904, 26579839, 26581406, 26601326, 26660957, 26793786, 26896864, 27026985, 27096335, 27226570, 27255234, 27400203. Exp. 05/23/2022 to 05/28/2023
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