medical Class I Updated 2023-10-25

Olympus Corporation of the Americas recalls Olympus High-Flow Insufflation Unit, Model UHI-4. For lapar

Recalled Product

Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.


Hazard / Issue

There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 04953170324147; All Serial Numbers
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →