China NMPA Product Recall - Patient programmer and implantable neurostimulator charger kit

Medtronic (Shanghai) Management Co., Ltd. has initiated a voluntary Class III recall concerning specific charging kits for patient programmers and implantable neurostimulators. This recall, formally reported on January 19, 2017, and publicly announced by the National Medical Products Administration (NMPA) on February 21, 2017, stems from a regulatory compliance issue: the production dates of affected units, encompassing models such as 37746 and 37754, predated the official approval of their NMPA product registration certificates. Despite this administrative discrepancy, Medtronic explicitly states that the products were manufactured in strict accordance with established production requirements, and their safety and efficacy remain entirely unaffected. The recall is a proactive measure to ensure full adherence to Chinese regulatory frameworks concerning product market authorization. Approximately 11 units were identified as affected, with 9 having already been distributed within China. As part of the required actions, Medtronic is issuing notification letters and facilitating the return of all unused affected products, underscoring its commitment to regulatory compliance while reassuring users that product performance and patient safety are not compromised.