China NMPA Product Recall - Cerebrospinal fluid shunt and accessories, lumbosacral-abdominal shunt assembly

The National Medical Products Administration (NMPA) announced on March 17, 2017, a voluntary Class III recall initiated by Medtronic (Shanghai) Management Co., Ltd. This action addresses certain Cerebrospinal Fluid Shunt and Accessories, including the Lumbosacral-Abdominal Shunt Assembly. Medtronic's investigation identified a rare potential issue: the accumulation of biological debris in the pressure regulating valve. This debris could restrict the free rotation of the internal magnet, potentially damaging the regulating mechanism when the device is exposed to a 3.0 Tesla Magnetic Resonance Imaging (MRI) environment. In response to this finding, Medtronic elected to recall the affected products. A Class III recall signifies that the use of or exposure to the product is not likely to cause adverse health consequences. Specific details regarding the models, specifications, and batch numbers of the involved products are contained within the "Medical Device Recall Event Report Form" associated with this NMPA announcement, reflecting Medtronic's commitment to patient safety and compliance with NMPA regulations.