HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling the HURRICANE RX Dilation Balloon 10MM 4CM, a medical device used for endoscopic dilatation of strictures in the biliary tree and sphincter of Oddi. The recalled product has a defect where the balloon develops a pinhole leak that causes it to lose pressure or fail to gain or maintain pressure during use, resulting in prolonged procedures. The affected balloons were distributed nationwide and are identified by 130 specific batch/lot codes.
The recall affects devices with lot codes ranging from 25608761 through 26706797. According to the recall record, no remedy is specified for consumers who have affected units.
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: 25608761, 25640116, 25640117, 25644834, 25649819, 25649824, 25649829, 25649834, 25678825, 25678830, 25678835, 25678839, 25678880, 25680560, 25704230, 25704231, 25704232, 25739169, 25739170, 25806714, 25819946, 25819947, 25819948, 25836147, 25836148, 25850475, 25850476, 25850477, 25850478, 25850479, 25850540, 25850541, 25878986, 25878987, 25878988, 25878989, 25878990, 25878991, 25930854, 25940128, 25940129, 25940130, 25963979, 25969161, 25969162, 25975788, 25975789, 25975790, 25975791, 26010399, 26010400, 26047895, 26047896, 26047897, 26047898, 26047899, 26048760, 26058432, 26059172, 26123198, 26123199, 26123240, 26123241, 26123242, 26123243, 26123252, 26123253, 26175502, 26175503, 26175504, 26175505, 26207999, 26208000, 26208001, 26208002, 26208003, 26240379, 26247286, 26247287, 26247288, 26247289, 26284152, 26284153, 26284154, 26284155, 26284156, 26324769, 26324771, 26324773, 26324775, 26350409, 26356442, 26366767, 26366768, 26366769, 26366770, 26366771, 26366772, 26366773, 26366774, 26406539, 26406560, 26406561, 26406562, 26435589, 26435590, 26435591, 26440046, 26457040, 26457041, 26473800, 26473801, 26489988, 26491481, 26491482, 26491483, 26491484, 26499145, 26543699, 26545849, 26545850, 26545851, 26546369, 26549973, 26559545, 26581409, 26581410, 26581827, 26600543, 26600544, 26621751, 26628098, 26638074, 26651704, 26651705, 26651706, 26651709, 26674679, 26675080, 26675081, 26677000, 26677001, 26677002, 26686240, 26696688, 26696689, 26706795, 26706796, 26706797, 2
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.