The FDA issued an early alert after Olympus issued a letter recommending the removal of certain High Flow Insufflation Units.
To notify the public of a potentially high-risk device issue, the FDA’s Center for Devices and Radiological Health issued the alert after Olympus told affected customers to consider removing affected devices from where they are used or sold.
Insufflation units insufflate the abdominal cavity and provide automatic suction and smoke evacuation. They help to facilitate laparoscopic observation and treatment.
Olympus’ warning stated that the software algorithm on its High Flow Insufflation Unit (models UHI, UHI-2 and UHI-3) requires correction. The company said it needs to address a potential issue that could lead to overpressure events. It previously discontinued the affected products and they haven’t been supported by repair for “many years,” according to the FDA alert. As a result, Olympus said it decided to remove these devices from the market.
In 2023, the company instructed customers to discontinue use of the UHI-4 regarding issues related to over-insufflation until corrective actions were identified and implemented. In 2025, the issues identified in that field correction action were addressed, and updated devices have been returned to clinical use.
Over-insufflation can lead to a number of patient harms during a procedure. Those include air embolism, arrythmias (bradycardia, asystole, or cardiac arrest), pneumothorax, kidney or urinary problems, hypoxia, subcutaneous emphysema, delay to treatment, more complex procedures and potentially death. The company reports two serious injuries and no deaths associated with the issue.
On Jan. 16, Olympus told affected customers to examine inventory and quarantine any identified devices immediately. Customers should immediately cease usage of any affected models in their inventory.
This article previously stated that Olympus discontinued the UHI-4. The company instructed users to discontinue use until corrective actions were identified and implemented. This has been updated.
