Atrium Medical Corporation has recalled 141 units of the Advanta V12 Covered Stent System, specifically the 10mm x 59mm x 80cm model used for restoring blood flow in arteries. The recall was initiated because the weld between the balloon and the catheter may fail, which can cause a loss of balloon pressure while a surgeon is attempting to deploy the stent. This defect could lead to an improperly placed stent or the need for additional medical procedures to correct the issue. These devices were manufactured in the United States and distributed internationally; consumers should contact their healthcare provider or the manufacturer regarding next steps.
A failure in the balloon-to-catheter weld can cause the balloon to lose pressure during the stent deployment process. If the balloon cannot maintain pressure, the stent may not expand or seat correctly in the artery, potentially leading to restricted blood flow or requiring emergency surgical intervention.
Manufacturer notification and coordination with healthcare providers.
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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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