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Boston Scientific Corporation recalls AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
Recalled February 5, 2025 · FDA recall Z-1025-2025 · Boston Scientific
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. · FDA Class II
Units
1144 units US; 60 units (OUS)
Sold at
Nationwide including Puerto Rico Foreign: To be provided
Description
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.
Product
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →