China NMPA Product Recall - CEREBASE DA Guide Sheath

The National Medical Products Administration (NMPA) announced on February 6, 2024, a significant voluntary Class I medical device recall initiated by manufacturer Medos International SARL, reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. This recall targets the CEREBASE DA Guide Sheath, registered under National Medical Device Registration Certificate No. 20233030046. The primary reason for this action stems from a series of complaints concerning the breakage of the distal delivery catheter component during use.

The Class I designation signifies that the device's use or exposure carries a reasonable probability of causing serious adverse health consequences or even death, underscoring the severity of the identified issue. In response, Medos International SARL is proactively withdrawing the affected products from the market. While specific inspection dates are not provided, the regulatory framework of the NMPA mandates such actions to ensure consumer safety. The detailed list of involved product models, specifications, and batch numbers is available in the accompanying "Medical Device Recall Event Report Form," ensuring comprehensive tracking and removal of potentially hazardous devices. This event highlights the critical importance of manufacturer vigilance and robust regulatory mechanisms in safeguarding public health within the medical device sector.