Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Reported: October 25, 2023 Initiated: September 22, 2023 #Z-0075-2024
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.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 3136 units
- Distribution
- US Nationwide distribution.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.. Recalled by Olympus Corporation of the Americas. Units affected: 3136 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 25, 2023. Severity: Critical. Recall number: Z-0075-2024.
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