FDA Issues Early Alert on Calyxo CVAC Device After Reported Death

The FDA has issued an early alert regarding Calyxo’s CVAC aspiration system, which has been linked to one reported death due to excessive kidney pressure during urinary stone removal procedures. The alert, published under the agency’s pilot program for high-risk device notifications, highlights a risk of reduced fluid outflow in patients with thick kidney fluid, potentially leading to serious injury or death. Calyxo has updated its instructions for use, advising urologists to halt fluid inflow if outflow is restricted and to stop irrigation when the kidney’s collecting system becomes obscured by opaque fluid.

Calyxo’s redesigned CVAC system, which received 510(k) clearance last year, includes a steerable ureteral catheter and an image-processing unit. The FDA is actively reviewing the situation and has urged healthcare providers to monitor its early alert webpage for further updates. The agency remains committed to informing the public as new details emerge regarding the potential risks associated with the device.