Cook Medical Incorporated has recalled 695 Zenith Alpha 2 Thoracic Endovascular Grafts (Catalog Prefix ZTA2-). These surgical devices may contain scrapings of PTFE coating that could be released into a patient's bloodstream during deployment. If released, these scrapings can cause blood vessel blockages (intravascular embolization), which may lead to serious health complications. The affected products were distributed to hospitals and clinics across 31 US states and 5 European countries.
The release of coating scrapings into the bloodstream can cause blockages in blood vessels. This restricted blood flow can damage vital organs or tissues and may lead to life-threatening complications requiring additional medical intervention.
Affected units may contain scrapings from the PTFE coating on the device deployment system.
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.
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Sources: FDA iRES · Raw API Response
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