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# Calyxo Updates CVAC Aspiration Instructions
- URL: https://www.fdaweb.com/calyxo-updates-cvac-aspiration-instructions/
- Published: 2025-03-20T12:00:00.000Z
- Updated: 2026-09-14T14:55:52.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158861

An FDA medical device early alert says the agency is aware that Calyxo has notified affected customers that its CVAC Aspiration Systems have updated instructions for use. The [alert](https://www.fda.gov/medical-devices/medical-device-recalls/early-alert-aspiration-system-issue-calyxo?utm%5Fmedium=email&utm%5Fsource=govdelivery) says Calyxo identified a new risk of injury during use of the system when patients have high viscosity fluid in the kidney at the start of the procedure, which can cause reduced fluid outflow that can lead to excessive pressure in the kidney.

“If the increased pressure in the kidney is not addressed,” FDA says, “serious injury or death may occur.” The alert says Calyxo reported one death associated with the issue.