FDA-Device2025-02-05Class II
AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
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
1399 units; 20 units (OUS)
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1026-2025Don't want to check this manually?
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