medical Class II Updated 2023-11-22

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

Distribution: Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom
Lot/Code Info: UDI-DI: 00650862853612 Lot Numbers: 464909, 464910
View official government recall

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