China NMPA Product Recall - Adjustable Steerable Diagnostic Catheters

Irvine Biomedical, Inc., a St. Jude Medical Company, initiated a voluntary Level II recall of specific models and batches of its Steerable Diagnostic Catheters, as reported by Abbott Medical Products (Shanghai) Co., Ltd. The National Medical Products Administration (NMPA) published this recall notice on September 4, 2020. The primary issue identified was a labeling error where the English label indicating the model number on the packaging did not accurately correspond to the product contained within the batch. This discrepancy prompted the manufacturer to take corrective action. The affected products are identified under Registration Certificate No.: 20153073669. Detailed information regarding the specific models, specifications, and batches impacted by this recall is available in the accompanying "Medical Device Recall Event Report Form." The required action for the company is the voluntary recall of these mislabeled devices to ensure product integrity and patient safety in adherence to regulatory standards set by the NMPA.