HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling HURRICANE RX DILATION BALLOON 10MM 2CM devices used for endoscopic dilatation of strictures in the biliary tree and Sphincter of Oddi. The recalled devices have a defect where the balloon develops a pinhole that causes it to lose pressure or fail to gain or maintain proper pressure, resulting in prolonged procedures. The devices were distributed nationwide across 16 specific lot/batch numbers with expiration dates ranging from May 9, 2022 to May 27, 2023.
Affected consumers can identify recalled devices by checking the batch number on their device against the following list: 25571372, 25673064, 25836146, 26010398, 26058426, 26123197, 26175501, 26216321, 26473779, 26759413, 26784680, 26848732, 26946145, 27121592, 27340635, and 27393787. The source does not specify what remedy an affected consumer should pursue.
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: Batches: 25571372, 25673064, 25836146, 26010398, 26058426, 26123197, 26175501, 26216321, 26473779, 26759413, 26784680, 26848732, 26946145, 27121592, 27340635, 27393787 GTIN: 08714729283867 Exp. 05/09/2022 to 05/27/2023
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.