China NMPA Product Recall - Cranial Treatment Guidance System (Neurosurgery), Spine Treatment Guidance System (Spinal Surgery), and ENT Treatment Guidance System (ENT Surgery)

Medtronic Navigation, Inc., in cooperation with Medtronic (Shanghai) Management Co., Ltd., has initiated a voluntary Class I recall impacting its neurosurgical, spinal surgery, and otolaryngology surgical navigation systems. This action, announced on May 22, 2024, addresses a critical software malfunction that may result in incorrect biopsy needle depth settings during procedures. The affected devices operate under National Medical Device Registration Certificate No. 20183010507. The National Medical Products Administration (NMPA) oversees this recall, with a Class I designation indicating the potential for serious adverse health consequences or death due to the defect. Medtronic is actively withdrawing these products from the market to mitigate risks, and specific details regarding models and batches are available in the associated recall report form.