Integra LifeSciences is recalling approximately 300 CODMAN BACTISEAL EVD Catheter Sets due to a defect in the external sterile pouch packaging. The defect involves a gap or weakness in the seal, which may compromise the sterility of the medical device before it is used. These catheters are used to access the brain's ventricles and drain cerebrospinal fluid to reduce intracranial pressure. Consumers and healthcare providers should identify affected units and contact the manufacturer for further instructions regarding the use or return of these devices.
A gap or weak seal in the sterile packaging allows contaminants to enter, potentially introducing bacteria or other pathogens into the sterile catheter. Because these devices are inserted directly into the ventricles of the brain, a non-sterile product poses a significant risk of serious infection, including meningitis or ventriculitis.
Manufacturer notification and return of product
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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