FDA reports Urgent Device Field Correction notice for CVAC Aspiration System

Calyxo sent an Urgent Device Field Correction notice to urologists on February 19, 2025, providing updated instructions on the use of their CVAC Aspiration System, the FDA reported.¹

Calyxo received FDA clearance for their redesigned CVAC System in March 2024.

Specifically, Calyxo had identified a new risk of injury when the CVAC Aspiration System is used in patients with high viscosity (thick) fluid in their kidneys at the start of the procedure. This can reduce fluid outflow, leading to excessive pressure in the kidneys that may result in injury or death.

At the time of the release, 1 death had been reported in relation to this issue.

Specifically, Calyxo shared the following instructions with affected health care professionals:

• “Do not continue to provide fluid inflow in the presence of unresolved slow or absent fluid outflow. Doing so can create an intrarenal pressure imbalance, which may result in serious injury or death.
• If a patient has cloudy, opaque (turbid), or suspected thick (high-viscosity) fluid observed in the kidney’s collecting system, stop irrigation immediately using the three-way stopcock.
• If visibility within the collecting system is completely obscured by opaque fluid, do not use the CVAC Aspiration System in the procedure.
• Diagnostic or therapeutic ureteroscopy is contraindicated in patients with untreated urinary tract infection. Patients with coagulation disorders, severe cardiopulmonary insufficiency, or uncontrolled diabetes should be managed appropriately.
• If drainage through the access sheath is desired, use a 13/15 Fr or larger Ureteral Access Sheath. The CVAC Aspiration System is compatible with 12/14 Fr Ureteral Access Sheaths and will provide limited outflow, which may over-pressure the kidney.
• Confirm your equipment is set up properly for use with the CVAC Aspiration System to monitor fluid outflow when low outflow is suspected. If there is a suspected slowing or lack of fluid outflow from the CVAC Aspiration System, stop irrigation inflow using the three-way stopcock.
• If visibility is sufficient to proceed, follow the evacuation procedure to clear the fluid in the kidney.”¹

These instructions specifically apply to the following device: Calyxo REF Number CVC127020-1 and User Manual L00018 Rev C (UDI-DI: 00860005357710).

The FDA noted that they are monitoring the situation and will continue to update the public on any significant new information. Health care professionals who experience an adverse reaction or quality issue related to these devices may contact MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

About the CVAC Aspiration System

The CVAC Aspiration System is used to “establish a channel during endoscopic urological procedures for the treatment and removal of urinary stones,” according to the agency.

Calyxo received FDA clearance for their redesigned CVAC System in March 2024.² According to the company, the redesign was initiated following 2 years of real-world use in order to further enhance the steerable ureteroscopic renal evacuation (SURE) procedure. Specifically, Calyxo explained that the updated system includes “direct visualization with dedicated irrigation channels and a large aspiration lumen.”

REFERENCES

1. Early alert: Aspiration System issue from Calyxo. News release. US Food & Drug Administration. Last updated March 20, 2025. Accessed March 21, 2025. https://www.fda.gov/medical-devices/medical-device-recalls/early-alert-aspiration-system-issue-calyxo

2. Calyxo announces FDA Clearance for new, redesigned CVAC System. News release. Calyxo. March 26, 2024. Accessed March 21, 2025. https://calyxoinc.com/calyxo-news/calyxo-fda-approved-cvac-system-kidney-stones/