Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Atrium iCAST Balloon Expandable Covered Stent Recalled by Atrium Medical Corporation Due to Firm received a complaint that a customer who...
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 iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85355 (Marketed OUTSIDE U.S. only) The iCAST Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.
Quantity: 246 (US: 183 units; Foreign: 63 units)
Why Was This Recalled?
Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v12 7 mm x 38 mm x 80 cm, due to the manifold (catheter hub) was printed as 7mm x 38 mm x 80 cm. The complaint was the result of incorrect dimensional information (7mm x 38mm x 80cm) printed on the manifiold (catheter hub). The complaint device physical dimensions matched the dimensional information displayed on the outer packaging and the device inner pouch. This was the only complaint received for this non-conformance.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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