Olympus Corporation of the Americas: EZDilate Wire Guided Balloon Recalled for Mislabeled Device Diameter

Agency Publication Date: October 25, 2024

Summary

Olympus Corporation of the Americas is recalling 209 units of the EZDilate Wire Guided Balloon, specifically Model BD-410X-1055, due to incorrect labels attached directly to the device. While the outer packaging is correct, the label on the device itself incorrectly lists diameters of 11 mm, 12 mm, and 13 mm, when the actual balloon sizes are smaller at 8.5 mm, 9.5 mm, and 10.5 mm. Using the wrong size during an endoscopic procedure to widen strictures in the digestive tract or the bile duct can lead to ineffective treatment and prolonged surgery time.

Risk

The discrepancy between the device label and the actual balloon size may cause medical professionals to use an appropriately sized balloon for the intended procedure, potentially resulting in insufficient dilation of the treatment area and extending the duration of the surgical procedure.

What You Should Do

Identify if you have the affected EZDilate Wire Guided Balloon by checking for Model/Catalog Number BD-410X-1055 and Lot Number 408987.
Verify the device by checking the UDI-DI number 821925033238 on the product packaging.
Be aware that while the 'Glo Cath Label' attached to the device may incorrectly state 11 mm, 12 mm, or 13 mm, the actual balloon sizes are 8.5 mm, 9.5 mm, and 10.5 mm.
Medical facilities and healthcare providers should immediately stop using devices from the affected lot and contact Olympus Corporation of the Americas at 1-800-848-9024 for specific return or replacement instructions.
Patients who have recently undergone an endoscopic dilation procedure and have concerns should contact their healthcare provider to discuss their treatment.
For additional questions regarding this recall, contact the FDA's medical device recall line at 1-888-463-6332.

Your Remedy Options

Other Action

Healthcare provider or manufacturer consultation

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

Affected Products

Product: EZDilate Wire Guided Balloon

Model / REF:

BD-410X-1055

UPC Codes:

821925033238

Lot Numbers:

408987

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95400

Status: Active

Manufacturer: Olympus Corporation of the Americas

Sold By: Hospital and medical supply channels

Manufactured In: United States

Units Affected: 209 units

Distributed To: California, Florida, Illinois, New Jersey, New York, Pennsylvania, Tennessee, Virginia, Wisconsin

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 you have the affected EZDilate Wire Guided Balloon by checking for Model/Catalog Number BD-410X-1055 and Lot Number 408987.

Verify the device by checking the UDI-DI number 821925033238 on the product packaging.

Be aware that while the 'Glo Cath Label' attached to the device may incorrectly state 11 mm, 12 mm, or 13 mm, the actual balloon sizes are 8.5 mm, 9.5 mm, and 10.5 mm.

Medical facilities and healthcare providers should immediately stop using devices from the affected lot and contact Olympus Corporation of the Americas at 1-800-848-9024 for specific return or replacement instructions.

Patients who have recently undergone an endoscopic dilation procedure and have concerns should contact their healthcare provider to discuss their treatment.

For additional questions regarding this recall, contact the FDA's medical device recall line at 1-888-463-6332.