Moderate FDA (Devices)·Z-0024-2025·Announced 2024-10-16

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.

What this means for you

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: udi-error
mis-labeling
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

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Same manufacturer · Atrium Medical Corporation

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Same hazard · udi error