China NMPA Product Recall - Intra-aortic balloon counterpulsation pump (trade names: AutoCAT 2, AutoCAT 2 WAVE)

Arrow International, Inc. initiated a voluntary recall of its Intra-Aortic Balloon Counterpulsation Pumps (IABPs), specifically the AutoCAT 2 and AutoCAT 2 WAVE models. This significant action, reported on June 18, 2020, and overseen by the National Medical Products Administration (NMPA) in China, addresses a critical product defect.The primary issue identified is that a component within the IABPs is susceptible to vibration failure. This flaw could lead to the sudden malfunction of the device or prevent it from starting, posing a serious risk to patient safety given the life-sustaining function of these pumps. Telefel Medical Devices Trading (Shanghai) Co., Ltd. communicated these concerns.Arrow International implemented a Level 1 recall, which is the most serious classification, indicating a reasonable probability that using or being exposed to the affected product could cause serious adverse health consequences or death. The recall encompasses specific products identified by their registration certificates (e.g., 20153211603, 2015308160, 20113211652) and batch numbers, detailed in an accompanying Medical Device Recall Event Report Form. This measure aims to prevent potential harm by removing affected devices from circulation.