China NMPA Product Recall - DLP single-stage intravenous cannulation

On March 14, 2012, Medtronic Inc., through its Chinese entity Medtronic (Shanghai) Management Co., Ltd., initiated a voluntary recall of specific models of its DLP® Single-Stage Intravenous Catheters. This action was prompted by reported product malfunctions and patient deaths linked to the use of these catheters beyond their intended indications, specifically during ventricular assist procedures. The main issue involved the cannula splitting within the reinforcing spring section during off-label application, leading to air embolism.

The catheters are designed for draining venous blood from the right heart during cardiopulmonary bypass procedures, with a labeled usage limit of up to six hours. The incidents occurred when the device was employed in ventricular assist device (VAD) applications, which falls outside its approved scope as specified in the Instructions for Use.

Operating under the regulatory oversight of the National Medical Products Administration (NMPA), Medtronic is updating the product's Instruction Manual. The revised manual will explicitly include ventricular assist procedures as a contraindication, emphasizing that the product should not be used beyond its defined purpose. Provincial Food and Drug Administrations are tasked with strengthening supervision of similar medical devices. Medtronic is also responsible for ensuring relevant physicians are informed about these critical updates to prevent further off-label use and safeguard patient well-being.