Cordis US Corp is recalling 21 units of the Smart Control Vascular Stent System ILIAC because the stents may be labeled as one size but actually contain a different size. This product mix-up affects stents distributed to medical facilities and hospitals in specific US states and Japan. No injuries have been reported at this time. Healthcare providers are advised to stop using the affected lots and contact the manufacturer to arrange for their return.
A stent labeled with the incorrect size could lead to a physician using the wrong device during a procedure, which may result in improper placement, ineffective treatment of the vascular condition, or the need for additional medical intervention.
Recall #: Z-1510-2025; Quantity: 20 units
Recall #: Z-1511-2025; Quantity: 1 unit
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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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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