Atrium Medical Corporation has recalled 11 iCast Covered Stents (Model Number 42616) because the Unique Device Identifier (UDI) printed on the distribution label is incorrect. These stents, measuring 6MMx16MMx120CM, were distributed to hospitals in Florida, Massachusetts, Michigan, Ohio, and Washington. Atrium Medical Corporation has notified affected customers via letter about the labeling error. No incidents or injuries have been reported related to this issue.
The recall is due to an error in the Unique Device Identifier (UDI), which is a code used to track and identify medical devices. An incorrect UDI on the label can lead to errors in inventory management or confusion regarding the specific product being used in a clinical setting.
Recall #: Z-0024-2025
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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