Boston Scientific is recalling 256 units of the Autotome RX 20mm CUT WIRE Cannulating Sphincterotome in the United States because foreign material may be present on the enclosed section of the cutting wire. This device, used during procedures to access the bile duct, may fail to bow or bend correctly due to this material. This defect can lead to significant delays during surgical procedures while the patient is under anesthesia.
The presence of foreign material on the wire prevents the device from achieving the necessary curvature (bowing) required for the medical procedure. This failure can result in the prolongation of the surgical procedure, increasing the time a patient is exposed to anesthesia and potential procedural risks.
Manufacturer notification and device return
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.
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Sources: FDA iRES · Raw API Response
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