China NMPA Product Recall - Surgical navigation system, neurosurgical navigation system

Medtronic Navigation Inc., with its agent Medtronic (Shanghai) Management Co., Ltd., initiated a Class I medical device recall under the National Medical Products Administration (NMPA) framework. The initial recall report was filed on November 20, 2018, with a supplementary update on April 9, 2019. The NMPA publicly announced these changes on April 11, 2019. The core issue involves the Surgical Navigation System and Neurosurgical Navigation System, specifically the Neurosurgery Synergy Cranial application software (version 2.2.0 and above). Complaints revealed an inaccurate depth gauge function. If the user sets the navigation projection length greater than the planned length, the system may display incorrect biopsy depth information. This critical malfunction could lead to excessively deep biopsy needle insertion, potentially causing injury to healthy brain tissue or vital anatomical structures during surgical procedures. A total of 160 affected units were identified for the Chinese market, with an increase of 17 units in the supplementary report. Medtronic's required actions are structured in three phases. Phase I, which began in November 2018, involved notifying affected hospitals and providing detailed problem descriptions and preventative measures. Phase II included a second communication to customers, informing them about an upcoming software upgrade service and distributing reminder cards to ensure correct application of the biopsy function. Phase III will focus on releasing and implementing the updated software version. Importantly, this corrective action plan does not necessitate the physical return of affected products.