Boston Scientific is recalling 985 units of the Obsidio Conformable Embolic device because a specific delivery method, known as the aliquot technique, can cause a dangerous lack of blood flow to the intestines. This device is used to stop bleeding in the lower gastrointestinal tract, but investigations have shown that using this particular technique poses a high risk of bowel ischemia (tissue death due to restricted blood flow). If this occurs, patients may require major emergency surgery, such as a bowel resection or a diverting colostomy. This recall was initiated voluntarily by the firm to warn healthcare providers and facilities against using this specific delivery method.
The aliquot technique used to deliver the embolic material can lead to unintended blockages in blood vessels supplying the intestines, resulting in tissue death (bowel ischemia). This complication often requires major surgical intervention to remove damaged sections of the bowel.
Cease use of the aliquot technique for specific procedures.
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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