FDA-Device2025-02-05Class II
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
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
1530 units (OUS)
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1035-2025Don't want to check this manually?
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