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

On May 6, 2022, Abbott Medical, through its subsidiary Abbott Medical Products (Shanghai) Co., Ltd., initiated a voluntary Class III recall of its Single-Use TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™. This action was reported to the National Medical Products Administration (NMPA). The recall stems from a reported issue where specific models and batches of the catheter displayed an error message, which subsequently disabled its pressure sensing function. This malfunction necessitated the replacement of the catheter during medical procedures. The company is taking required actions to address this product deficiency under the NMPA's regulatory framework. The Class III designation indicates that while the issue may cause temporary or reversible adverse health consequences, the probability of serious adverse health consequences is considered remote. Abbott Medical is actively working to identify and retrieve all affected units, with detailed information on product models, specifications, and batches provided in an accompanying Medical Device Recall Event Report Form. This recall underscores a commitment to patient safety and product reliability.