FDA recall Z-0325-2022

Boston Scientific Corporation · Class II · device

Product

HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2021-10-21
Report date
2021-12-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0325-2022