Recall archive / FDA device enforcement
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency o... — FDA record Z-0291-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 21, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
- Classification
- Class II
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 141 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0291-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00650862853612 Lot Numbers: 464909, 464910 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 22, 2023
- Recall initiation date
- Sep 21, 2023
- Center classification date
- Nov 10, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.