Wilson-Cook Medical Inc. is recalling 153 units of Teslatome Bipolar Sphincterotomes because the devices may contain a physical void in the material that separates internal wires. This defect can cause an inappropriate path of electrical current during surgical cutting procedures. These medical devices are used by clinicians during endoscopic retrograde cholangiopancreatography (ERCP) to help guide wires and cut tissue in the biliary ducts.
A void in the device material can cause electrical current to travel along an unintended path during surgery, potentially leading to tissue damage, burns, or other internal injuries to the patient.
Units affected are associated with specific Work Order Numbers / RPNs listed in the serial numbers field.
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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