FDA-Device2021-12-08Class II
HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
Hazard
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Sold states
US Nationwide distribution.
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0322-2022More Boston Scientific Corporation recalls
- FDA-Device2026-07-08CRE Pro Wireguided 12-15mm 240cm
- FDA-Device2026-07-08CRE Pro Wireguided 10-12mm 240cm
- FDA-Device2026-07-08CRE Pro Wireguided 15-18mm 240cm
- FDA-Device2026-07-08CRE Pro Wireguided 6-8mm 240cm
- FDA-Device2026-07-08CRE Wireguided 8-10mm 240cm
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