The FDA has issued a warning to physicians regarding failure to deploy Boston Scientific's AXIOS Stent and Electrocautery Enhanced Deployment Systems.[1] These systems are associated with three deaths and 167 serious injuries.[1] The problem lies in the rotating Luer fitting on the distal end of the delivery system handle, which can become detached during preparation, insertion, or use of the device.[1] This may delay the procedure or risk peritonitis due to leakage of contents from the bowel, pseudocyst, or gallbladder into the peritoneum.[1] Boston Scientific initiated a Class 2 recall (Recall Z-0773-2021) on December 1, 2020, which was completed on July 14, 2023.[1] The company sent notifications to customers instructing them to immediately stop distributing or using the affected products and to verify the lot numbers.[1] The stent is intended for implantation for a maximum of 60 days in case of pseudocyst or walled-off necrosis of the pancreas and should be removed after their disappearance.[1] The cause, according to the FDA, is an error in process control.[1]