China NMPA Product Recall - Controllable catheter sheath with hemostatic valve (Agilis NxT Steerable Introducer)

St. Jude Medical, through Abbott Medical Products (Shanghai) Co., Ltd., has initiated a voluntary Class II recall of its controllable catheter sheaths with hemostatic valves, specifically the Agliss NxT Steerable Introducer (National Medical Device Registration Certificate 20153031169). Announced on May 24, 2024, the recall stems from a critical manufacturing issue: the dilator within the device is too short to extend properly beyond the catheter sheath. This defect could potentially compromise the safety and effectiveness of medical procedures. The recall is overseen by the National Medical Products Administration (NMPA), with a Class II designation indicating a moderate risk where the defect might cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. St. Jude Medical is taking this corrective action to address potential patient safety concerns. Detailed information concerning affected models, specifications, and batch numbers is provided in the accompanying "Medical Device Recall Event Report" document.