FDA-Device2025-02-05Class II
AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
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
495 units US; 2 units(OUS)
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1024-2025More Boston Scientific Corporation recalls
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