Recall Z-0286-2021— Boston Scientific Corporation

Name: FDA recall Z-0286-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-16

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2020-09-16. It names one FDA 510(k) clearance: K130484. Product: Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960 The device is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow duct segments, as well as the Sphincter of Oddi.. Reason: RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2020-09-16
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 Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960 The device is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow duct segments, as well as the Sphincter of Oddi.

Reason for recall

RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.

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