Boston Scientific has recalled approximately 461 POLARSHEATH Steerable Sheath 12F devices (REF M004CRBS3050) because a manufacturing error may cause the inner lining of the device to peel or flake off. If this delamination occurs during a medical procedure, such as while flushing the sheath or inserting a catheter, fragments of the device could be released into the patient's bloodstream. This could lead to a serious medical emergency known as an embolism, where a fragment blocks a blood vessel. These devices were manufactured in the United States and distributed to hospitals and medical facilities internationally.
The inner layer of the sheath shaft can peel away, allowing plastic fragments to enter the patient's circulatory system. This poses a critical risk of embolism, which can block blood flow and lead to severe organ damage or other life-threatening complications.
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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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