China NMPA Product Recall - Implantable neurostimulation system

On August 8, 2014, Medtronic (Shanghai) Management Co., Ltd. reported to the National Medical Products Administration (NMPA) a voluntary recall by its manufacturer, Medtronic Inc., for an implantable neurostimulation system (Registration Certificate No.: CFDA (Imported) 2013 No. 3210203). The recall stemmed from a critical manufacturing issue affecting the L284 integrated circuit, crucial for the device's I-channel. Investigations revealed that a detached clip in the production equipment caused a metal handle to damage L284 chips during the wafer handling process. A significant concern was that while some damaged chips failed quality tests, others erroneously passed, indicating a potential for defective devices to enter circulation. The affected products, identified by specific serial numbers including NKM724776H, are intended for Parkinson's disease and tremor control therapy. Medtronic confirmed these particular recalled units were not sold or imported into China. The NMPA directed provincial and municipal food and drug administrations to reinforce supervision and management of medical devices, ensuring product safety even without direct market impact within China for this specific recall.