Olympus Medical has initiated a recall of its High-Flow Insufflation Unit, model UHI-4, following reports of patient complications that may have resulted from over-insufflation of the abdominal cavity. The complications include arrhythmias reported as short cardiac arrests, gas embolism, and one death during surgical procedures where the devices were used.
The UHI-4 unit is designed to inflate the abdomen or colon with carbon dioxide gas during laparoscopic or endoscopic surgeries. The FDA has classified this recall as class I due to the serious nature of the reported incidents. The FDA alert stated that the use of the affected unit could lead to severe adverse health consequences, including air embolism, arrhythmias, collapsed lung, kidney or urinary problems, oxygen cut off to organs, and even death. The recall encompasses 3,136 devices in the U.S., distributed from May 29, 2012, to August 17, 2023. Olympus Medical has advised its U.S. customers to discontinue the use of the unit unless no alternatives are available.