China NMPA Product Recall - Contact pressure photosensitive ablation catheter

On August 19, 2019, Abbott Medical Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its contact pressure photosensitive ablation catheters. This action was reported to the Shanghai Food and Drug Administration and falls under the regulatory oversight of the National Medical Products Administration (NMPA).

The recall was prompted by a significant quality issue discovered during a market sampling inspection. It was found that the tip and ring electrodes of the affected catheters, registered under certificate number 20163772841, failed to meet the company's specified DC resistance technical requirements. This non-conformance indicates a deviation from the established performance and safety standards for the medical device.

As a direct result, Abbott Medical Products (Shanghai) Co., Ltd. is voluntarily removing the non-compliant products from distribution. Comprehensive details concerning the specific models, specifications, and batch numbers involved in this recall are available in the "Medical Device Recall Event Report Form." This recall highlights the company's commitment to maintaining product quality and ensuring patient safety in compliance with NMPA's medical device regulations.