Olympus Corporation of the Americas: UHI-4 High-Flow Insufflation Units Recalled for Patient Cardiac Arrest Risk

Agency Publication Date: October 18, 2023

Summary

Olympus Corporation of the Americas has recalled 3,136 Olympus High-Flow Insufflation Units (Model UHI-4) used during laparoscopic surgeries. The recall was initiated after reports of patients suffering arrhythmias and short cardiac arrests during surgical procedures. These serious medical events are linked to the UHI-4 potentially over-inflating the abdominal cavity with gas. Olympus has notified healthcare facilities through a voluntary firm-initiated letter to address these safety concerns.

Risk

The device may cause over-insufflation of the abdominal cavity, which can lead to abnormal heart rhythms (arrhythmias) or brief periods of cardiac arrest. Several patient incidents involving cardiac arrest during surgery have already been reported in connection with this defect.

What You Should Do

Identify if your facility uses the Olympus High-Flow Insufflation Unit, Model UHI-4, by checking for UDI-DI 04953170324147 on the device label or packaging.
Check the serial number on the back of the unit; this recall affects all serial numbers for the UHI-4 model.
Stop using the UHI-4 unit if your medical facility has received specific safety instructions or a stop-use notice from Olympus.
Medical professionals and healthcare providers should contact Olympus Corporation of the Americas at 3500 Corporate Pkwy, Center Valley, PA 18034, or their local Olympus representative for technical guidance and potential corrective actions.
If you are a patient who has recently undergone laparoscopic surgery and have concerns, contact your healthcare provider to discuss your recovery and any potential complications.
Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this medical device recall.

Your Remedy Options

Other Action

Manufacturer Notification and Guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Olympus High-Flow Insufflation Unit, Model UHI-4

Model / REF:

UHI-4

UPC Codes:

04953170324147

Lot Numbers:

All Serial Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92932

Status: Active

Manufacturer: Olympus Corporation of the Americas

Sold By: Medical distributors; Direct sales to healthcare facilities

Manufactured In: United States

Units Affected: 3136 units

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if your facility uses the Olympus High-Flow Insufflation Unit, Model UHI-4, by checking for UDI-DI 04953170324147 on the device label or packaging.

Check the serial number on the back of the unit; this recall affects all serial numbers for the UHI-4 model.

Stop using the UHI-4 unit if your medical facility has received specific safety instructions or a stop-use notice from Olympus.

Medical professionals and healthcare providers should contact Olympus Corporation of the Americas at 3500 Corporate Pkwy, Center Valley, PA 18034, or their local Olympus representative for technical guidance and potential corrective actions.

If you are a patient who has recently undergone laparoscopic surgery and have concerns, contact your healthcare provider to discuss your recovery and any potential complications.

Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this medical device recall.