Olympus High-Flow Insufflation Unit Model UHI-4 Recalled for Cardiac Complications
Olympus recalls the UHI-4 High-Flow Insufflation Unit used in laparoscopic surgery after reports of patients experiencing cardiac arrhythmias and short cardiac arrests during procedures. Incidents may result from over insufflation of the abdominal cavity.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. Per the severity rubric, FDA Class I recalls never score below 4. The reported cardiac arrhythmias and short cardiac arrests during surgery constitute significant injury reports.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus High-Flow Insufflation Unit, Model UHI-4, a device used in laparoscopic surgical procedures. Following reports of patients experiencing cardiac arrhythmias and short cardiac arrests during procedures where the UHI-4 was used, the manufacturer initiated this recall. These cardiac events may have resulted from over insufflation of the abdominal cavity caused by the device.
Approximately 3,136 units have been distributed nationwide. All serial numbers of the UHI-4 model are included in the recall. The device is identified by UDI-DI: 04953170324147.
Those with UHI-4 devices should contact Olympus Corporation of the Americas for further guidance regarding this recall.
The recalled product
- Product
- Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- cardiac-arrhythmia
- cardiac-arrest
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 04953170324147
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
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