Atrium iCAST and Advanta V12 Stents Recalled for Incorrect Hub Labeling
Atrium Medical Corporation is recalling specific iCAST and Advanta V12 covered stents because the catheter hub was printed with incorrect dimensional information.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates the physical device dimensions were correct and only the hub labeling was incorrect, representing a minor labeling error without reported injuries.
Plain-English summary
Atrium Medical Corporation is recalling 246 units of the Atrium iCAST Balloon Expandable Covered Stent (7mm x 22mm x 120cm) and the Atrium Advanta V12 Balloon Expandable Covered Stent (7mm x 22mm x 120cm). The recall affects Part Number 85455 (Lots 240735, 240523) and Part Number 85355 (Lot 240734). The devices were distributed nationwide in the United States and in Germany, Great Britain, Austria, Ireland, Netherlands, France, Italy, Sweden, and San Marino.
The recall was initiated after the firm received a complaint that a customer ordered a 7mm x 22mm x 120cm device but received a unit with a catheter hub printed as 7mm x 38mm x 80cm. The physical dimensions of the device matched the information on the outer packaging and inner pouch, but the manifold (catheter hub) displayed incorrect dimensional information. This was the only complaint received for this non-conformance.
Healthcare providers and customers should check their inventory for the specific part numbers and lot numbers listed above. If the devices are found, they should be removed from use and returned to Atrium Medical Corporation.
The recalled product
- 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 Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85355 (Marketed OUTSIDE U.S. only) The iCAST Covered Stent is…
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Stents
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Part Number 85455: Lots 240735
- 240523
- Part Number 85355: Lot 240734
Distribution
Distributed nationwide across the United States.
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