Recall Z-0075-2024— Olympus Corporation of the Americas

Name: FDA recall Z-0075-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-22

Class I · Ongoing

Class I FDA medical device recall by Olympus Corporation of the Americas, initiated 2023-09-22. It names 2 FDA 510(k) clearances: K122180, K110294. Product: Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.. Reason: 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..

Recalling firm: Olympus Corporation of the Americas
Classification: Class I
Status: Ongoing
Initiated: 2023-09-22
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K122180 — HIGH FLOW INSUFFLANTION UNITOlympus Medical Systems Corporation·cleared 2012-11-13
K110294 — HIGH FLOW INSUFFLATION UNIT UHI-4Olympus Medical Systems Corporation·cleared 2011-11-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.