Reported Oct 25, 2023 · Ongoing
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Olympus Corporation of the Americas
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
- Lot codes and dates
- UDI-DI04953170324147; All Serial Numbers
- Amount recalled
- 3136 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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