China NMPA Product Recall - PTA balloon dilation catheter

Bard Peripheral Vascular, Inc. initiated a voluntary Class III recall of its PTA balloon dilatation catheters, as reported by Bard Medical Technology (Shanghai) Co., Ltd. and published by the National Medical Products Administration (NMPA) on April 10, 2020. The recall stems from an identified error in the balloon diameter marking for a specific model and batch of these medical devices. This labeling inaccuracy could lead to the use of an incorrectly sized catheter during percutaneous transluminal angioplasty (PTA) procedures, potentially impacting patient safety. The NMPA, as the regulatory authority, oversees this action to ensure compliance with medical device standards. A Class III recall indicates that while the defect is unlikely to cause serious adverse health consequences, corrective action is necessary to maintain product integrity and prevent potential issues. Bard Peripheral Vascular, Inc. is required to identify and remove all affected products from distribution. Comprehensive details regarding the specific models, specifications, and batch numbers involved are provided in an accompanying Medical Device Recall Event Report Form. This measure underscores the company's commitment to patient safety and adherence to regulatory guidelines.