Boston Scientific is recalling 4,060 units of the iSLEEVE 14F Expandable Introducer Set, a medical device used to facilitate access to the femoral artery during vascular procedures. The recall was initiated because the device's hemostatic valve can leak, which may lead to blood loss or other surgical complications. No specific injuries were detailed in the report, but the firm is removing specific affected batches from the market worldwide. Consumers and healthcare providers should check their inventory for the specific batch numbers listed and contact Boston Scientific for further instructions on returning the product.
A leak in the hemostatic valve can cause uncontrolled bleeding during a vascular procedure, potentially requiring additional medical intervention or prolonging the surgical time. This defect compromises the device's ability to maintain a seal while instruments are being passed through the vascular system.
Removal of specific batches from the market.
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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