Z-1032-2025 Class II Ongoing
FDA device recall Z-1032-2025 was initiated by Boston Scientific Corporation on December 20, 2024 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 263 units (OUS).
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
- 263 units (OUS)
Product Description
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520
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: 08714729904540 Lot Numbers: 33336402, 33336404, 33336405, 33336411, 33392916, 33392917, 33393302, 33411607, 33437479, 33548501, 33577903, 33704371, 33712822, 33986537, 34017087, 34017088, 34017089, 34028458, 34065579, 34065660, 34083271, 34083272