China NMPA Product Recall - Implantable neurostimulation electrodes

Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Level 1 recall of its implantable neurostimulation electrodes, specifically involving the Stimloc single-use sterile drill caps. The recall, reported under National Medical Products Administration (NMPA) Index No. JGXX-2021-10317 and published by the Shanghai Municipal Drug Administration on June 24, 2021, stems from a manufacturing defect. The core issue involves an additional protrusion on the edge of the support clip in certain batches of Stimloc drill caps, which are utilized after craniocerebral surgery. This defect has the potential to compromise the normal use and performance of the product, posing a significant concern for patient safety and product efficacy. As a required action, Medtronic (Shanghai) Management Co., Ltd. has taken proactive steps to remove the affected products from the market. A Level 1 recall signifies the highest potential for serious adverse health consequences or death. Detailed information regarding the specific models, specifications, and affected product batches is available in the associated "Medical Device Recall Event Report Form" for stakeholders' reference. This action underscores the company's commitment to product quality and patient safety within the regulatory framework overseen by the NMPA.