The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Please be aware, this recall is a correction, not a product removal.
- Product Names: Olympus High Flow Insufflation Unit
- Product Codes: See Recall Database Entry
- Model Numbers: UHI-4
- Distribution Dates: May 29, 2012 to August 17, 2023
- Devices Recalled in the U.S.: 3,136
- Date Initiated by Firm: August 9, 2023
The Olympus High Flow Insufflation Unit inflates the abdomen or colon with carbon dioxide gas. The unit may be used during laparoscopic or endoscopic surgeries, such as minimally invasive abdominal surgeries, colonoscopies, or vein harvesting. The unit also provides automatic suction and smoke evacuation.
Reason for Recall
Olympus is recalling its Olympus High Flow Insufflation Unit because the unit may over-insufflate (inflate) air into the body with no warning or alarm.
Olympus Recalls Olympus High Flow Insufflation Unit Due to Over-Inflation
The use of the affected unit may cause serious adverse health consequences, including air embolism, and arrythmias including bradycardia, asystole, or cardiac arrest. Other risks include collapsed lung, kidney or urinary problems, oxygen cut off to organs, and air trapped under the skin. Other necessary or complex medical procedures may be delayed because of over-insufflation, and death may occur.
There have been reports of 21 malfunctions, 10 serious injuries, and one death.
Who May be Affected
- People undergoing procedures requiring insufflation.
- People at a greater risk include:
- Patients with a history of cardiac arrythmias or chronic respiratory disease
What to Do
On October 25, 2023, Olympus sent all affected customers an Urgent Medical Device Corrective Action Letter, providing updates to the letter sent September 22, 2023.
The letter requested customers to:
- Carefully read the contents of the Corrective Action Letter.
- Inspect inventory and identify any UHI-4 High flow insufflation Unit(s).
- Discontinue use of all units until the investigation into the cause of the problem is completed and additional instructions are provided by Olympus. Quarantine and mark units appropriately by your site to prevent usage.
- If a facility does not have alternatives or is unable to obtain alternatives, they may use the UHI-4 with extreme caution per the considerations outlined in the Letter.
- Ensure all personnel are completely knowledgeable and thoroughly trained on the contents of the Letter.
- Complete the enclosed response form and return it to the recall partner, Sedgwick, via email at Olympus5578@sedgwick.com or by fax at 866-367-6717. For any questions about the acknowledgment form, call the Sedgwick team at 855-215-4972.
- Identify your customers and forward them the Letter if the Unit has been distributed further.
- Report complaints, including injuries, with over-insufflation during the procedure to Olympus’ Technical Assistance Center at 1-800-848-9024, option 1.
Customers in the U.S. with questions about this recall should contact Olympus at 1-800-848-9024, Option 1.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.