China NMPA Product Recall - Disposable magnetoelectric positioning pressure monitoring ablation catheter TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

The National Medical Products Administration (NMPA) announced on July 18, 2022, that Abbott Medical Products (Shanghai) Co., Ltd. initiated a voluntary recall of specific batches of its Single-Use TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™. The recall was prompted by identified errors in the information stored within the erasable programmable memory (EEPROM) of certain devices. Although the document does not detail specific inspection dates, the recall was reported by the company due to this product issue. This action falls under the NMPA's regulatory oversight for medical devices. The recall is classified as Level III, indicating a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. Abbott Medical is required to provide detailed information on the affected product models, specifications, and batches in a Medical Device Recall Event Report Form, ensuring compliance with NMPA standards to address the identified product deficiency.