Z-1034-2025 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
- 519 units (OUS)
Product Description
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
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: 08714729904564 Lot Numbers: 33169261, 33169263, 33209127, 33243075, 33243077, 33243856, 33255964, 33488328, 33787031, 33787032, 33853395, 33882221, 33882222, 33899656, 33909280, 33979053, 33979055, 34027245, 34027246, 34035523, 34035524, 34052776, 34052778, 34161831, 34161832, 34161833, 34161834, 34190943, 34190944, 34190945, 34192326, 34192327, 34201917, 34203537, 34203539, 34204795, 34223677, 34223679, 34226399, 34226540, 34243427, 34243428, 34375175, 34381803, 34585408, 34731098