Cadwell Industries Inc: Cascade IOMAX Cortical Module Recalled for Unintended Electrical Stimulation

Agency Publication Date: July 12, 2024

Summary

Cadwell Industries Inc. is recalling 26 units of the Cascade IOMAX Cortical Module (REF: 190296-200), an electroneurodiagnostic medical device used for monitoring nerve function. The device may contain a defective printed circuit board that can damage other internal components, potentially causing the device to deliver unintended electrical stimulation to a patient. These units were distributed in Illinois and California, as well as internationally, between approximately February and May 2024.

Risk

A defect in the circuit board can cause electrical malfunctions within the device, leading to pulses of electricity being delivered to the patient that were not planned by the medical professional. This unintended stimulation poses a risk of patient injury or interference with critical surgical monitoring.

What You Should Do

Locate your Cascade IOMAX Cortical Module and check the reference number (REF: 190296-200) and the Universal Device Identifier (UDI: 00840067100653).
Verify if your device's serial number matches one of the 26 affected units: 19029603AA0224001, 19029603AA0224002, 19029603AA0224003, 19029603AA0224004, 19029603AA0224005, 19029603AA0224006, 19029603AA0224007, 19029603AA0224008, 19029603AA0224010, 19029603AA0224021, 19029603AA0224027, 19029603AA0324006, 19029603AA0324007, 19029603AA0324008, 19029603AA0324009, 19029603AA0324010, 19029603AA0424001, 19029603AA0424002, 19029603AA0424003, 19029603AA0424006, 19029603AA0424007, 19029603AA0424008, 19029603AA0424009, 19029603AA0424010, 19029603AA0524003, or 19029603AA0524004.
If your serial number is listed, contact Cadwell Industries Inc. at 909 N Kellogg St, Kennewick, WA, or via their customer support channels to arrange for a remedy.
Healthcare providers should consult with the manufacturer regarding the continued use or replacement of affected modules to ensure patient safety during neurodiagnostic procedures.
For further information or to report adverse events, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification

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

Affected Products

Product: Cascade IOMAX Cortical Module

Model / REF:

REF: 190296-200

UPC Codes:

00840067100653

Lot Numbers:

19029603AA0224001

19029603AA0224002

19029603AA0224003

19029603AA0224004

19029603AA0224005

19029603AA0224006

19029603AA0224007

19029603AA0224008

19029603AA0224010

19029603AA0224021

19029603AA0224027

19029603AA0324006

19029603AA0324007

19029603AA0324008

19029603AA0324009

19029603AA0324010

19029603AA0424001

19029603AA0424002

19029603AA0424003

19029603AA0424006

19029603AA0424007

19029603AA0424008

19029603AA0424009

19029603AA0424010

19029603AA0524003

19029603AA0524004

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94764

Status: Active

Manufacturer: Cadwell Industries Inc

Sold By: Direct Sales; Medical Distributors

Manufactured In: United States

Units Affected: 26 units

Distributed To: Illinois, California

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

Risk

What You Should Do

Locate your Cascade IOMAX Cortical Module and check the reference number (REF: 190296-200) and the Universal Device Identifier (UDI: 00840067100653).

Verify if your device's serial number matches one of the 26 affected units: 19029603AA0224001, 19029603AA0224002, 19029603AA0224003, 19029603AA0224004, 19029603AA0224005, 19029603AA0224006, 19029603AA0224007, 19029603AA0224008, 19029603AA0224010, 19029603AA0224021, 19029603AA0224027, 19029603AA0324006, 19029603AA0324007, 19029603AA0324008, 19029603AA0324009, 19029603AA0324010, 19029603AA0424001, 19029603AA0424002, 19029603AA0424003, 19029603AA0424006, 19029603AA0424007, 19029603AA0424008, 19029603AA0424009, 19029603AA0424010, 19029603AA0524003, or 19029603AA0524004.

If your serial number is listed, contact Cadwell Industries Inc. at 909 N Kellogg St, Kennewick, WA, or via their customer support channels to arrange for a remedy.

Healthcare providers should consult with the manufacturer regarding the continued use or replacement of affected modules to ensure patient safety during neurodiagnostic procedures.

For further information or to report adverse events, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: Cascade IOMAX Cortical Module

Model / REF:

REF: 190296-200

UPC Codes:

00840067100653

Lot Numbers:

19029603AA0224001

19029603AA0224002

19029603AA0224003

19029603AA0224004

19029603AA0224005

19029603AA0224006

19029603AA0224007

19029603AA0224008

19029603AA0224010

19029603AA0224021

19029603AA0224027

19029603AA0324006

19029603AA0324007

19029603AA0324008

19029603AA0324009

19029603AA0324010

19029603AA0424001

19029603AA0424002

19029603AA0424003

19029603AA0424006

19029603AA0424007

19029603AA0424008

19029603AA0424009

19029603AA0424010

19029603AA0524003

19029603AA0524004