China NMPA Product Recall - Impulse and Expo Angiographic Catheter

Boston Scientific Corporation, through its subsidiary Boston International Medical Trading (Shanghai) Co., Ltd., has initiated a voluntary Class II recall for its Impulse and Expo Angiographic Catheters. Publicly announced on April 3, 2024, the recall addresses a critical product integrity concern: the potential for material detachment due to delamination of the polyurethane liner within the catheter. This manufacturing issue could result in fragments of the catheter liner detaching during a medical procedure, potentially posing health risks to patients if left inside the body. This action is undertaken under the regulatory framework of the National Medical Products Administration (NMPA), with the affected devices registered under National Medical Device Registration Certificate 20153031974. Boston Scientific is proactively retrieving affected products, and specific details regarding models, specifications, and batch numbers are provided in an accompanying Medical Device Recall Event Report Form. This voluntary recall highlights the company's commitment to product safety and compliance with NMPA standards, aiming to mitigate potential patient harm by ensuring non-conforming devices are removed from circulation.