Atrium Medical Corporation recalls Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm
Recalled 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
Hazard / Issue
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Issued by
FDA
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