Class II

Medical Device Recall: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530

Boston Scientific Corporation · December 20, 2024

Reason for Recall

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.

Distribution

Nationwide including Puerto Rico Foreign: To be provided

States Affected

NATIONWIDE

Quantity Affected

91 units (OUS)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1033-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.