AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
FDA Recall #Z-1027-2025 — Class II — December 20, 2024
Product Description
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
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
309 units
Distribution
Nationwide including Puerto Rico Foreign: To be provided
Code Information
GTIN: 08714729979333 Lot Numbers: 32901294, 33223930, 33328461, 33413626, 33459702, 33686175, 33686176, 33766912, 33814306, 33825089, 33860266, 33920983, 33920984, 33930917, 34020982, 34020983, 34111459, 34111480, 34111481, 34135618, 34135619, 34136372, 34271635, 34297652, 34316296
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated