China NMPA Product Recall - Tiered-therapy Cardioverter/Defibrillator

On August 9, 2019, the National Medical Products Administration (NMPA) published notice NMPA Index No. JGXX-2019-10511 regarding a significant medical device recall. St. Jude Medical Coordination Center BVBA, the manufacturer, initiated a voluntary Level 1 recall for its implantable Tiered-therapy Cardioverter/Defibrillator devices, with St. Jude Medical Products (Shanghai) Co., Ltd. reporting the action. The affected products carry Registration Certificate Nos. 20153212692 and 20153212693.

The primary reason for this urgent recall is an identified electrical malfunction within the devices, specifically caused by damage to the internal aluminum wires. This defect presents a serious health risk to patients, prompting the highest level of recall. A Level 1 classification indicates a reasonable probability that using or being exposed to the faulty product will lead to severe adverse health consequences or death.

Under the NMPA's regulatory framework, the company is required to take prompt action to identify, retrieve, and manage all affected units. This ensures patient safety and adherence to medical device regulations. Additional detailed information, including specific models and batch numbers, is provided in the accompanying "Medical Device Recall Event Report Form."