Atrium iCAST Balloon Expandable Covered Stent recall
Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12 Balloon…
Why was Atrium iCAST Balloon Expandable Covered Stent 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number 85455: Lots 240735, 240523; Part Number 85355: Lot 240734
- Product
- Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12 Balloon…
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 246 (US: 183 units; Foreign: 63 units)
- Distribution
- Worldwide distribution-US (nationwide) and countries of: Germany, Great Britain, Austria, Ireland, Netherlands, France, Italy, Sweden, and San Marino.
- Recall date
- August 2, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)