China NMPA Product Recall - Arterial and venous catheterization

Medtronic, Inc. initiated a voluntary recall of its arterial and venous catheters on February 10, 2014, after reports indicated cannula body cracking near the suture ring, occurring at an incidence rate of 0.06%. This critical issue posed risks of insufficient blood flow, potentially causing local ischemia or inadequate perfusion in patients. Additionally, difficulties encountered during catheter insertion or removal could lead to surgical delays, vascular injury, dissection, or other complications, which might be fatal. The National Medical Products Administration (NMPA) published this recall notice on February 25, 2014, having received a report from Medtronic (Shanghai) Management Co., Ltd. on February 14. The affected products, identified by CFDA (Imported) No. 20133665005, were intended for cardiopulmonary bypass surgery. Although the recall primarily impacted regions like the USA and Europe and no affected products were imported or sold in China, the NMPA directed all provincial and municipal food and drug administrations to enhance their supervision and management of related medical devices.