HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530
FDA Recall #Z-1033-2025 — Class II — December 20, 2024
Product Description
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530
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.
Recalling Firm
Boston Scientific Corporation — Marlborough, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
91 units (OUS)
Distribution
Nationwide including Puerto Rico Foreign: To be provided
Code Information
GTIN: 08714729904557 Lot Numbers: 33335139, 33335340, 33336413, 33511491, 34015885, 34065661, 34068983, 34101926
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated