China NMPA Product Recall - Implantable Neurostimulation Lead

Medtronic Inc. initiated a voluntary Class I recall for specific batches of its implantable neurostimulation lead electrodes. This action, documented by the National Medical Products Administration (NMPA) under Index No. JGXX-2021-10411 and published on July 27, 2021, addresses a critical manufacturing defect. The issue stems from certain StimLoca drill caps, which were found to possess an additional protrusion on the edge of the support clip. This flaw could significantly impede the product's normal functionality and compromise its performance. The recall pertains to the implantable neurostimulation lead electrode (Registration Certificate No. 20163212970). Medtronic (Shanghai) Management Co., Ltd. reported this defect, prompting the NMPA to classify it as a Class I recall, signifying a high potential for serious adverse health consequences. Detailed information regarding affected product models, specifications, and batches is available in the associated "Medical Device Recall Event Report Form." Medtronic is taking this proactive step to uphold product quality and patient safety.