Maquet recalls intra-aortic balloon pumps

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.

""

Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.

Around the web

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."

Philips introduced a new CT system at ECR aimed at the rapidly growing cardiac CT market, incorporating numerous AI features to optimize workflow and image quality.

Trimed Popup
Trimed Popup