Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Atrium Advanta V12 Covered Stent System Recalled by Atrium Medical Corporation Due to Balloon-to-catheter weld failure that may cause loss of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Atrium Medical Corporation directly.
Affected Products
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
Quantity: 141 units
Why Was This Recalled?
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Where Was This Sold?
Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom
About Atrium Medical Corporation
Atrium Medical Corporation has 150 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report