China NMPA Product Recall - PTA balloon dilation catheters (Coyote OVER-THE-WIRE PTA Balloon Dilatation Catheters)

Boston Scientific Corporation has initiated a voluntary Class II recall of its Coyote OVER-THE-WIRE PTA Balloon Dilatation Catheters. This action, overseen by the National Medical Products Administration (NMPA) and published on December 19, 2025, addresses a critical product concern. The recall stems from reports of potential inflation and depression difficulties encountered when these catheters are utilized within peripheral blood vessels. The affected devices, identified under National Medical Device Registration Certificate No. 20173030463, are being withdrawn from the market to mitigate potential risks to patient safety. While specific inspection dates are not detailed in the provided information, the recall itself serves as a regulatory measure prompted by the identified performance issues. The company's proactive voluntary recall underscores its commitment to product safety and compliance with NMPA regulations. Further details regarding the specific models and specifications involved are referenced in an accompanying 'Medical Device Recall Event Report Form.' This action ensures that products with potential functional deficiencies are promptly removed, safeguarding public health.