FDA-Device2025-02-05Class II
AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
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
31 units
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1028-2025Don't want to check this manually?
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