Arrow International, Inc. Recall
On June 18, 2020, Arrow International, Inc. voluntarily recalled its product, AutoCAT 2 and AutoCAT 2 WAVE (国械注进20153211603、国械注进20153081603、国食药监械（进）字2011 No.3211652). The product involved may have a component in IABP vulnerable to vibration failure, which will eventually cause a sudden stop or failure to start IABP. This is a Class I recall, for which serious health hazards may be or have been caused by the medical device. Many countries, such as the US, Australia and China, are all influenced by this recall. Since China NMPA enhances the post-market surveillance, Bradynuoen can lead manufacturers in compliance with China regulations.
