China NMPA Product Recall - Subcutaneous implantable cardioverter defibrillator

The National Medical Products Administration (NMPA) has announced a Class I voluntary recall initiated by Boston Scientific International Medical Trade (Shanghai) Co., Ltd. This recall, an update to a report filed on December 3, 2020, was publicly announced on February 23, 2021. It concerns their Subcutaneous Implantable Cardioverter Defibrillator (SICF), identified by Registration Certificate No. 国械注进20153212410. While the specific reasons or main violations leading to the recall are not detailed in this public notice, the company has taken proactive measures to voluntarily recall the affected medical devices. The Class I designation, assigned by the Shanghai Drug Administration, signifies that there is a reasonable probability that the use of or exposure to the product could cause serious adverse health consequences or death. Detailed information regarding affected product models, specifications, and batches is available in the accompanying "Medical Device Recall Event Report Form." This action underscores the robust regulatory oversight of the NMPA and the company's commitment to ensuring product safety.