HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling Hurricane RX Dilation Balloon 6MM 2CM devices used for endoscopic dilatation of strictures in the biliary tree and Sphincter of Oddi. The devices were distributed nationwide and may have a pinhole in the balloon that causes it to lose pressure or fail to gain or maintain pressure, which can result in prolonged procedures. The affected products have GTIN 8714729283829 and include 24 specific batch numbers with expiration dates ranging from May 23, 2022 to May 28, 2023.
The recall affects multiple batches of this medical device. The record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Reason for recall: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure Distribution: US Nationwide distribution. 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.