FDA recall Z-0075-2024

Product

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

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2023-09-22

Report date

2023-10-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0075-2024