China NMPA Product Recall - Neurosurgical navigation system (trade name: Stealthstation)

Medtronic Navigation Inc. initiated a voluntary recall of its Neurosurgical Navigation System (Stealthstation), as documented by the National Medical Products Administration (NMPA) on September 7, 2015, with the recall report dated July 27, 2015. This action, referenced under NMPA Index No. JGXX-2015-10192, addressed a significant safety concern regarding the device, which is distributed in China by Medtronic (Shanghai) Management Co., Ltd. The primary issue involved potential damage to the adhesive between the ball assembly and the biopsy needle shaft. This could lead to the ball assembly moving, causing an inaccurate display of the biopsy needle tip's position on screen, often indicating a deeper location than its actual placement. Such inaccuracies posed severe risks, including biopsy of incorrect tissue, potential damage to non-target brain tissue or blood vessels, and the necessity for additional surgical procedures. Medtronic confirmed that the affected product models and batch numbers (e.g., 9733068, batches 066503515, 066504315, 066506515) were not imported or sold within China. Consequently, specific corrective actions for China were deemed "Not applicable." However, the NMPA requested provincial drug administrations to enhance their supervision and management of similar medical devices to safeguard public health, while the recall primarily impacted regions like the United States, Canada, and Pakistan.