Olympus Recalls Insufflator Units Over Heart Concerns, Requests No More Use Of The Device

Olympus Medical has issued a recall of its High-Flow Insufflation Unit after reports of cardiac events during surgical procedures performed while using the device. The company has also requested providers stop using the device unless no alternative is available.

Olympus Medical initiated a recall in August of some 3,000 High-Flow Insufflation Units, Model UHI-4, after reports of serious adverse events, including arrythmias and cardiac arrests. The US Food and Drug Administration labelled the recall class I, its most serious type.

There have been reports of 21 malfunctions, 10 serious injuries, and one death, according to the FDA.