FDA-Device2025-02-05Class II
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
Boston Scientific Corporation
Hazard
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Sold states
Nationwide including Puerto Rico Foreign: To be provided
Affected count
519 units (OUS)
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1034-2025Don't want to check this manually?
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