Boston Scientific Corporation: Medical Device Recall in 2021 - (Recall #: Z-0320-2022)

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 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890

Product Classification:

Class II

Date Initiated: October 21, 2021

Date Posted: December 8, 2021

Recall Number: Z-0320-2022

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: 08714729283805 Lot Numbers: 25612668, 25649812, 25704208, 25771760, 25878552, 26000695, 26010387, 26058284, 26087172, 26087173, 26123181, 26324742, 26366746, 26406513, 26429808, 26499853, 26527374, 26573853, 26638827, 26651718, 26665448, 26893604, 27026984, 27074109, 27145234, 27162321, 27255235, 27306699. Exp. 05/19/2022 to 05/13/2023

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated