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FDASeptember 22, 2023device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

04953170324147

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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