China NMPA Product Recall - Contact pressure photosensitive ablation catheter

On May 25, 2020, the National Medical Products Administration (NMPA) published details regarding a voluntary Level II recall initiated by St. Jude Medical Products Co., Ltd., and reported by Abbott Medical Products (Shanghai) Co., Ltd. The recall concerns the TactiCath Quartz contact pressure photoablation catheter (Registration Certificate No.: 国械注进20163772841). The primary issue identified is the potential for the loss of contact pressure signal during the use of these medical devices. In response to this product quality concern, the company is undertaking several required actions. These include a voluntary recall of the affected catheters, actively informing all relevant customers about the known data pertaining to this issue, and reinforcing the operational recommendations outlined in the product instructions for users encountering such problems. It is noted that, as of the publication date, no patient injury events directly attributable to the loss of pressure signal have been reported within China. This action underscores the company's commitment to ensuring product safety and quality under the NMPA's regulatory oversight.