Calyxo Reports Death Associated with Aspiration System Issue

Calyxo has identified a new injury risk during use of its CVAC aspiration system when patients have high viscosity fluid in the kidney at the beginning of the procedure.

This can cause reduced fluid outflow, which can lead to excessive pressure in the kidney. If this increased pressure isn’t addressed, serious injury or death may occur.

The company has reported one death related to this issue.

The CVAC system (CVAC aspiration system and CVAC image processor) is used to establish a channel during endoscopic urological procedures to treat and remove urinary stones.

Calyxo issued a letter to affected customers on February 19, 2025 indicating that CVAC aspiration systems have updated instructions for use. Several actions were recommended in the company’s Urgent Device Field Correction notice.

Fluid inflow should not be provided in the presence of unresolved slow or absent fluid outflow. This can create an intrarenal pressure imbalance. If a patient has turbid or high-viscosity fluid observed in the kidney’s collection system, irrigation should be stopped immediately using the three-way stopcock.

If visibility in the collecting system is completely obscured by opaque fluid, the CVAC aspiration system should not be used in the procedure. Diagnostic or therapeutic ureteroscopy is contraindicated in patient with an untreated urinary tract infection (UTI). 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.

In January, Calyxo published the complete 30-day outcomes from the ASPIRE (ASPiration to Improve Renal Calculi Removal Effectiveness) clinical trial in the Journal of Endourology.