China NMPA Product Recall - Anchored Balloon Trapper™ Exchange Device

The National Medical Products Administration (NMPA) has announced a voluntary Class III recall initiated by Creganna Medical for its Trapper™ Exchange Device. This recall, reported by Boston Scientific International Medical Trading (Shanghai) Co., Ltd. on July 6, 2021, addresses a critical product defect concerning specific models and batches. The primary issue identified is a poor connection between the device's seat and the balloon cavity. This manufacturing flaw can result in significant difficulties or complete failure of distal balloon inflation during use. Such a malfunction could compromise the device's intended therapeutic function and potentially impact patient procedures. The Trapper™ Exchange Device, registered under certificate number 20213030169, is subject to this recall due to the potential for operational failure directly linked to the manufacturing defect. Creganna Medical, as the manufacturer, is taking proactive steps to mitigate risks associated with these faulty units by implementing a voluntary recall. The details regarding the affected models, specifications, and batch numbers are provided in an accompanying Medical Device Recall Event Report Form. This action underscores the manufacturer's commitment to product safety and compliance with regulatory standards overseen by the NMPA, ensuring that defective medical devices are promptly removed from circulation to protect public health.