Z-0291-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 22, 2023
- Initiation Date
- September 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 141 units
Product Description
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered stent sizes. In Canada, the Advanta V12 Covered Stent indication excludes renal arteries. REF: 85361
Reason for Recall
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Distribution Pattern
Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom
Code Information
UDI-DI: 00650862853612 Lot Numbers: 464909, 464910