Boston Scientific Recalls Obsidio Conformable Embolic: Heightened Risks of Bowel Ischemia for Lower GI Bleeding Patients
Boston Scientific Corporation has initiated a recall of the Obsidio Conformable Embolic, a premixed embolic agent used in minimally invasive procedures to block blood flow to specific blood vessels. This recall, classified as a Class I recall by the FDA, represents the most severe type of recall due to the potential for serious injuries or even death associated with the use of these devices. The recall affects 1,594 units distributed in the U.S. between May 8, 2023, and February 8, 2024.
The Obsidio Conformable Embolic, designed for single-use applications, is employed to embolize hypervascular tumors and occlude blood flow in peripheral blood vessels experiencing bleeding or hemorrhaging. However, Boston Scientific has identified a critical issue with the product’s use in lower gastrointestinal (GI) bleeding embolization procedures, particularly when delivered using the aliquot technique, a commonly utilized method in such procedures.
The risk associated with delivering Obsidio Embolic using the aliquot technique for lower GI bleeding embolization procedures is a significantly heightened risk of bowel ischemia. This condition may necessitate major surgical interventions such as bowel resection and/or diverting colostomy. Additionally, it could lead to non-target embolization or the restriction of blood and oxygen flow to organs like the small bowel, resulting in prolonged hospitalization, the requirement for additional surgeries, or even death.
Filing For Monetary Compensation
Victims of injuries or families who have lost loved ones due to complications from the use of Obsidio Embolic in lower GI bleeding embolization procedures may have grounds for legal action. Filing a lawsuit seeking damages involves several critical steps, beginning with consulting an experienced product liability attorney. These attorneys possess the knowledge and expertise to navigate the complexities of product liability law and advocate for the rights of victims and their families.
In the lawsuit process, victims and their families need an attorney to assist them in gathering evidence, building a strong case, and negotiating with the responsible parties or their insurers. Attorneys will work diligently to establish liability and prove that the injuries or death resulted from the use of the defective product. By leveraging their legal expertise, these attorneys can pursue compensation for various damages, including medical expenses, lost income, pain and suffering, and wrongful death.
Victims of bowel ischemia or other severe complications resulting from the use of Obsidio Conformable Embolic may face significant physical, emotional, and financial burdens. Medical treatments for these complications can be extensive and costly, leading to financial strain and emotional distress for the victims and their families. Furthermore, the impact of permanent injuries or the loss of a loved one cannot be understated, causing long-term suffering and grief.
Given the complexities and challenges associated with product liability lawsuits, having a knowledgeable and dedicated attorney by your side is crucial. Parker Waichman LLP understands the immense hardships faced by victims of defective medical products and is committed to providing compassionate legal representation. Our experienced attorneys will tirelessly advocate for your rights and pursue maximum compensation for your injuries or losses. If you have been harmed by the Obsidio Conformable Embolic, don’t hesitate to contact us for a free consultation and take the first step toward obtaining the justice and compensation you deserve.
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