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Olympus Corporation of the Americas recalls Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Recalled October 25, 2023 · FDA recall Z-0075-2024 · Olympus Corporation of the Americas
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. · FDA Class I
Units
3136 units
Sold at
US Nationwide distribution.
Description
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.
Product
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →