Z-1031-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2025
- Initiation Date
- December 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38 units
Product Description
AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
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 Pattern
Nationwide including Puerto Rico Foreign: To be provided
Code Information
GTIN: 08714729904632 Lot Numbers: 33740402, 33785754, 34037422