China NMPA Product Recall - Floating tube

The National Medical Products Administration (NMPA) published a recall notice on April 15, 2019, concerning a voluntary Class III recall initiated by Edwards Lifesciences LLC, through its agent Edwards (Shanghai) Medical Supplies Co., Ltd., on April 3, 2019. The recall addresses specific batches of Edwards Lifesciences LLC's floating catheters (National Medical Device Registration Certificate 20163774711, model 110F5).

The core issue identified was an error in the printed balloon inflation volume on the catheter itself. The device inaccurately indicated a 0.5ml inflation volume, despite the instruction manual specifying the correct volume as 0.8ml. This discrepancy is critical as insufficient balloon inflation could impede the catheter from achieving its proper position, obstruct the molding process, and potentially require device removal and reinsertion, leading to surgical delays.

While the product is distributed across regions including Canada, Europe, the Middle East, and Asia Pacific, the affected batches were not sold within China. Consequently, no domestic sales or patient complaints related to this particular issue were reported in China. The primary required action was for the manufacturer to report this voluntary recall to the NMPA, fulfilling regulatory reporting obligations for medical devices even without direct market impact in China.