FDA Issues Safety Alert for CVAC Aspiration System from Calyxo

On Mach 20, the FDA issued an early alert regarding a safety issue with the CVAC Aspiration System from Calyxo. This system, used in endoscopic urological procedures for treating urinary stones, has been identified as posing a risk of injury, especially when thick or high-viscosity fluid is present in the kidney at the start of the procedure. The presence of such fluid can lead to reduced fluid outflow and excessive pressure in the kidney, potentially resulting in serious injury or death.

One fatality has been linked to this issue.

Calyxo has issued a recall and sent an urgent field correction notice to healthcare providers, urging them to follow updated instructions when using the system.

Instructions include stopping fluid inflow if slow or absent fluid outflow is observed, halting irrigation immediately when opaque fluid is detected, and ensuring proper equipment setup to prevent excessive pressure.

The FDA is monitoring the situation and will continue to provide updates on this potentially high-risk device issue.