Recall Z-0323-2022— Boston Scientific Corporation

Name: FDA recall Z-0323-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-21

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2021-10-21. It names one FDA 510(k) clearance: K130484. Product: HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920. Reason: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure.

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2021-10-21
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K130484 — MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETERBoston Scientific Corp·cleared 2013-08-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.