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

Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall for its Cerebrospinal Fluid Shunt and Accessories, and Lumbosacral-peritoneal shunt assembly, governed by NMPA Index No. JGXX-2017-10231. This action stemmed from an internal investigation, prompted by five global reports received between February 2015 and November 2016, detailing discrepancies between valve pressure settings on hand tools and radiographic imaging results.The primary issue identified is the rare accumulation of biological debris within the pressure regulating valve. This debris can restrict the free rotation of the internal magnet, potentially damaging the regulating mechanism or causing polarity reversal when exposed to a 3.0 Tesla MRI. Notably, this issue is not observed with 1.5T MRI fields, and no patient illnesses, injuries, or fatalities have been reported.As part of the required actions, Medtronic has issued a notification letter to customers. Users are advised that if difficulties arise in adjusting or reading valve settings, radiographic imaging should be utilized to confirm the correct setting. Should hand tool readings contradict radiographic images, the radiographic image should be prioritized for accurate placement determination. The recall report was submitted on February 20, 2017.