HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling Hurricane RX Dilation Balloons (4mm, 2cm) used for endoscopic procedures to widen strictures in the biliary tree and Sphincter of Oddi. The recall affects balloons distributed nationwide with specific lot numbers ranging from 25612668 through 27306699, with expiration dates between May 2022 and May 2023. The balloons are subject to recall because a pinhole defect can cause them to lose pressure or fail to gain or maintain pressure during use, which may result in prolonged procedures.
The product defect creates a potential safety concern for patients undergoing biliary and sphincter procedures. Consumers who have received one of the recalled balloons should check the product lot number and expiration date against those listed in the recall. The recall record does not specify a remedy or recommended course of 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: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.