China NMPA Product Recall - Implantable cardioverter defibrillator (trade name: EVERA)

The National Medical Products Administration (NMPA) released a notice concerning a voluntary product recall initiated by Medtronic Inc. for specific Implantable Cardiac Defibrillators, known by the trade name EVERA. Reported by Medtronic (Shanghai) Management Co., Ltd. on August 26, 2016, and publicized by the NMPA on September 9, 2016, the recall addresses devices manufactured between August 27, 2013, and October 8, 2013. The primary issue stems from a circuit element defect creating a low-resistance path, which causes rapid battery depletion in affected devices, unrelated to the battery itself. Operating under the regulatory oversight of the NMPA, this notice references the product's registration certificate, CFDA (Imported) 2014 No. 3213428. Medtronic confirmed that the particular products subject to this recall were neither imported into nor sold within China. Therefore, no direct corrective actions like product retrieval or patient notifications are required domestically. However, the NMPA instructed provincial food and drug administrations to enhance their supervision and management. The recall's impact is primarily in regions such as the USA, Australia, Finland, and France.