Boston Scientific Corporation: Medical Device Recall in 2021 - (Recall #: Z-0322-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910

Product Classification:

Class II

Date Initiated: October 21, 2021

Date Posted: December 8, 2021

Recall Number: Z-0322-2022

Event ID: 88991

Reason for Recall:

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

Status: Ongoing

Product Quantity:

Code Information:

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

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated