China NMPA Product Recall - Delivery catheter (C315HIS type)

Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall of its C315HIS delivery catheters, as announced by the National Medical Products Administration (NMPA) on December 13, 2021. The recall stems from an identified issue where certain Medtronic electrode leads are unable to pass through specific batches of the C315HIS delivery catheter. This malfunction could potentially delay implantation surgery if a new catheter is required during a procedure. The affected products are specifically from three batches of the C315HIS delivery catheter (Registration Certificate No.: 20153033120). Medtronic reported no patient injuries or adverse events worldwide related to this problem at the time of the recall. The company's action is limited to the retrieval of unused delivery catheters from the identified batches. No measures or patient management recommendations have been issued for delivery catheters already utilized in surgical procedures. This voluntary recall demonstrates Medtronic's adherence to regulatory standards set by the NMPA, ensuring product safety and quality within the medical device industry.