iCast Covered Stent Recalled for Unique Device Identifier Labeling Error
Atrium Medical Corporation is recalling 11 iCast Covered Stents (Model 42616) due to an error in the Unique Device Identifier (UDI) printed on the distribution label. No illnesses or injuries have been reported.
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: FDA Class II labeling error with no reported illnesses or injuries. This fits the definition of a minor labeling error affecting device identification on the distribution label.
Plain-English summary
Atrium Medical Corporation is recalling 11 iCast Covered Stent devices, Model Number 42616 (6MMx16MMx120CM), in response to an error in the Unique Device Identifier (UDI) printed on the product's distribution label. The recalled units are from lot number 508083, with serial numbers 508083031 through 508083042, and were distributed to healthcare facilities in Florida, Massachusetts, Michigan, Ohio, and Washington.
The UDI error affects the product's identification on the distribution label. No illnesses or injuries related to this labeling error have been reported.
Healthcare facilities and distributors in the affected states who received devices from lot 508083 should contact Atrium Medical Corporation regarding the recall. The U.S. Food and Drug Administration is monitoring this Class II recall under number Z-0024-2025.
The recalled product
- Product
- iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Stent
- Hazard
- Affected units
- 11
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 (13)
- UDI-DI: 00650862426168
- Lot Number: 508083
- Serial Numbers: 508083031
- 508083032
- 508083034
- 508083035
- 508083036
- 508083037
- 508083038
- 508083039
- 508083040
- 508083041
- 508083042
Distribution
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