Boston Scientific Corporation: Medical Device Recall in 2021 - (Recall #: Z-0324-2022)

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 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930

Product Classification:

Class II

Date Initiated: October 21, 2021

Date Posted: December 8, 2021

Recall Number: Z-0324-2022

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: 25644951, 25649190, 25650286, 25651334, 25654287, 25947916, 25947918, 26010397, 26058298, 26406532, 26435581, 26449368, 26533973, 26555544, 26868194, 27074110, 27269956, 27384708. GTIN: 08714729283843 Exp. 05/27/2022 to 05/26/2023

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated