Scientia Vascular, Inc. is recalling 120 Socrates 38 Aspiration Catheters (127 cm length, Model SC038-127-001) due to a manufacturing defect in the packaging. The catheter, which is used to restore blood flow in patients suffering from acute ischemic strokes, may have channels or gaps in the packaging seals that compromise the product's sterility. No incidents or injuries have been reported to date.
A breach in the sterile barrier of a surgical device can allow bacteria and other contaminants to enter, potentially causing serious infections or complications during stroke treatment procedures.
The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute ischemic stroke.
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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