Olympus High-Flow Insufflation Unit recall
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Why was Olympus High-Flow Insufflation Unit 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 04953170324147; All Serial Numbers
- Product
- Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 3136 units
- Distribution
- US Nationwide distribution.
- Recall date
- October 25, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)