China NMPA Product Recall - Guidance system, left atrial appendage occluder

Boston Scientific International Medical Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall on August 28, 2015, pertaining to its Guidance Systems and Left Atrial Appendage Occlusion Devices. The primary concern identified was a mis-tightening issue with the hemostatic valve. This problem occurs if the valve is tightened while the dilator sheath is in place, potentially leading to increased blood leakage during device placement. The recall affects all lot numbers sold in China for specific models of these devices, which are approved under the National Medical Products Administration (NMPA) framework.

To address this, Boston Scientific International Medical Trading (Shanghai) Co., Ltd. is implementing two key corrective actions. Firstly, the company will issue an Emergency Field Corrective Action customer notice. This notice will reinforce the existing Instructions for Use (IFU) and provide comprehensive, updated guidance on the proper technique for using the hemostatic valve to prevent mis-locking, ensure a secure seal, and mitigate the risk of blood leakage. Secondly, the company is committed to directly notifying all relevant clients to ensure they are fully informed about the issue and the necessary corrective measures. These actions are designed to enhance safe product usage and patient outcomes.