Calyxo CVAC Aspiration System Recalled for Excessive Intrarenal Pressure Risk

Agency Publication Date: March 21, 2025

Summary

Calyxo, Inc. is recalling 11,246 units of the CVAC Aspiration System (REF: CVC127020-1) and User Manual L00018. The manufacturer is updating the product labeling to include additional instructions for treating patients with thick or high-viscosity fluid in the kidney. To date, no incidents or injuries have been reported related to this issue.

Risk

The device can cause excessive pressure inside the kidney if fluid continues to be pumped in while the outflow of fluid is slow or blocked. This pressure imbalance can lead to internal injury during endoscopic kidney or urinary tract procedures.

What You Should Do

This recall involves the CVAC Aspiration System (Model CVC127020-1) and its accompanying User Manual L00018 Revision C.
Identify the affected products by checking the REF code CVC127020-1 and the Unique Device Identifier (UDI-DI) 00860005357710 printed on the packaging or device labels.
Stop using the recalled device. Contact Calyxo, Inc. or your specialized medical distributor to arrange for a labeling update, product return, replacement, or correction.
Healthcare providers should consult the updated labeling for specific instructions on managing fluid inflow and outflow when treating patients with high-viscosity kidney fluids.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance or to report any adverse events.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: CVAC Aspiration System and User Manual L00018

Model / REF:

CVC127020-1

UDI:

00860005357710

Includes User Manual L00018 Rev C. Intended for endoscopic examination and treatment of the urinary tract and kidney interior.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96340

Status: Active

Manufacturer: Calyxo, Inc.

Sold By: Direct to hospitals; Specialized medical distributors

Manufactured In: United States

Units Affected: 11,246

Distributed To: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia

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

This recall involves the CVAC Aspiration System (Model CVC127020-1) and its accompanying User Manual L00018 Revision C.

Identify the affected products by checking the REF code CVC127020-1 and the Unique Device Identifier (UDI-DI) 00860005357710 printed on the packaging or device labels.

Stop using the recalled device. Contact Calyxo, Inc. or your specialized medical distributor to arrange for a labeling update, product return, replacement, or correction.

Healthcare providers should consult the updated labeling for specific instructions on managing fluid inflow and outflow when treating patients with high-viscosity kidney fluids.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance or to report any adverse events.