Maquet has issued a Class I recall on more than 5,000 intra-aortic balloon pumps (IABPs) in the United States due to a false blood detection alarm and the entrance of fluid into the devices. The IABPs are cardiac assist devices used for patients with acute coronary syndrome or complications from heart failure.Maquet warns if the device does not work, of if therapy is stopped without a replacement available, immediate and serious health consequences could occur, including death.
All CS100i, CS100 and CS300 IABPs manufactured from July 2003 to June 16, 2017, have been recalled—a total of 5,049 devices.
According to Maquet, customers with affected IABP units were sent a notice July 17 informing them of risks associated with the devices and instructions about how to minimize those risks.
The company said it would contact customers to schedule on-site service to install gaskets and upgrade software to remove the potential false blood detection alarm.