Scientia Vascular, Inc. is recalling one unit of the Plato 17 Microcatheter (REF PL17-160-090) because of a manufacturing defect that created small channels in the packaging pouch seal. This defect can compromise the sterile barrier of the device, which is used to help deliver therapeutic materials and fluids during brain and peripheral blood vessel procedures. No injuries or incidents have been reported in relation to this recall.
A breach in the sterile barrier can allow contaminants to enter the packaging, potentially leading to serious infections or other medical complications for patients undergoing interventional or diagnostic procedures. There are currently no reports of injury associated with this manufacturing defect.
Used to assist in delivery of therapeutic devices, embolization materials, and infusion of diagnostic agents.
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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