FDA Device recall Z-0327-2022

HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi

FDA Device
Class II
ongoing
Published 2021-12-08

On 2021-12-08 the FDA classified a Class II recall of HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi by Boston Scientific, citing balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0327-2022
Classification	Class II
Status	ongoing
Initiated	2021-10-21
Published	2021-12-08
Last updated	2026-09-13 11:56 UTC
Company	Boston Scientific
Distribution	US

Product

HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960

Reason

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

Identifiers

code_info	Batches: 25608761, 25640116, 25640117, 25644834, 25649819, 25649824, 25649829, 25649834, 25678825, 25678830, 25678835,… 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, 2

code_info

Batches: 25608761, 25640116, 25640117, 25644834, 25649819, 25649824, 25649829, 25649834, 25678825, 25678830, 25678835,…

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, 2

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0327-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.