Merit Medical Systems, Inc. is recalling 447 units of the 10Fore Hemostasis Valve due to a manufacturing defect involving a silicone quad ring. The ring may be deformed or damaged, which can cause pieces of the material to enter the patient's fluid pathway during medical procedures. This device is used to maintain blood control while physicians move diagnostic or interventional tools in and out of the body.
A damaged or deformed ring can break off and create a foreign body in the bloodstream, which could lead to serious medical complications like blood vessel blockages. While no specific injuries are mentioned, the presence of foreign material in a patient's cardiovascular system poses a significant health risk.
Intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices.
Intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices.
Intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices.
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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