FDA-Device2025-02-05Class II
AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
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
38 units
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1031-2025Don't want to check this manually?
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