Boston Scientific Corporation: Medical Device Recall in 2021 - (Recall #: Z-0326-2022)

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 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950

Product Classification:

Class II

Date Initiated: October 21, 2021

Date Posted: December 8, 2021

Recall Number: Z-0326-2022

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:

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

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated