Class II

Medical Device Recall: iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

Atrium Medical Corporation · September 9, 2024

Reason for Recall

There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.

Distribution

US Nationwide distribution in the states of FL, MA, MI, OH, WA.

States Affected

NATIONWIDE

Quantity Affected

11 devices

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0024-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.