China NMPA Product Recall - Single-use radiofrequency ablation electrode catheters (Sterile Electrode Catheters for Intracardiac Ablation)

On August 6, 2019, the National Medical Products Administration (NMPA) published a recall notice (Index No. JGXX-2019-10502) concerning a voluntary recall by Medtronic, Inc. The recall, reported by Medtronic (Shanghai) Management Co., Ltd., involves specific models of their single-use radiofrequency ablation electrode catheters for intracardiac ablation (RF), operating under Registration Certificate No.: 20153213975. The core issue prompting this Class III recall is that certain product models were not accurately listed on the registration certificate. This indicates an administrative non-compliance with regulatory listing requirements rather than an identified product performance or safety defect. As a required action, Medtronic, Inc. is initiating a voluntary recall of the affected catheters. Detailed information on the specific models, specifications, and batches involved is provided in the associated "Recall Event Report Form" attachment, reinforcing the NMPA's regulatory framework for ensuring medical device adherence to registration standards.