Recall Z-0291-2024— Atrium Medical Corporation
Class II · Ongoing
Class II FDA medical device recall by Atrium Medical Corporation, initiated 2023-09-21. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Atrium Medical Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-21
- Firm location
- Merrimack, NH, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.