FDA recall Z-0286-2021

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 for recall

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

Distribution

Worldwide distribution - US Nationwide and International distribution.

Key facts

Status

Ongoing

Initiation date

2020-09-16

Report date

2020-11-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0286-2021