Recalled Product
- Product Names: Olympus High Flow Insufflation Unit
- Product Codes: See Recall Database Entry
- Model Numbers: UHI-4
- Distribution Dates: May 29, 2012 to August 17, 2023
- Devices Recalled in the U.S.: 3,136
- Date Initiated by Firm: August 9, 2023
Device Use
The Olympus High Flow Insufflation Unit inflates the abdomen or colon with carbon dioxide gas. The unit may be used during laparoscopic or endoscopic surgeries, such as minimally invasive abdominal surgeries, colonoscopies, or vein harvesting. The unit also provides automatic suction and smoke evacuation.
Reason for Recall
Olympus is recalling its Olympus High Flow Insufflation Unit because the unit may over-insufflate (inflate) air into the body with no warning or alarm.
Olympus Recalls Olympus High Flow Insufflation Unit Due to Over-Inflation
The use of the affected unit may cause serious adverse health consequences, including air embolism, and arrythmias including bradycardia, asystole, or cardiac arrest. Other risks include collapsed lung, kidney or urinary problems, oxygen cut off to organs, and air trapped under the skin. Other necessary or complex medical procedures may be delayed because of over-insufflation, and death may occur.
There have been reports of 21 malfunctions, 10 serious injuries, and one death.
Who May be Affected
- People undergoing procedures requiring insufflation.
- People at a greater risk include:
- Children
- Elderly
- Patients with a history of cardiac arrythmias or chronic respiratory disease
