FDA Issues Early Alert for Calyxo’s CVAC Aspiration System

The FDA has issued an early alert regarding Calyxo’s CVAC aspiration system, warning of a potential risk of excessive kidney pressure during procedures to remove urinary stones. This issue has been linked to one reported death.

Key Concerns:

• Cause: Patients with thick fluid in the kidney at the start of the procedure may experience reduced fluid outflow, leading to dangerously high kidney pressure.
• Potential Consequences: If not properly managed, serious injury or death may occur.
• Mitigation Measures: To address the risk, Calyxo issued updated usage instructions to healthcare providers on February 19, 2025.

This alert is part of the FDA’s early notification pilot program, which provides advanced warnings about high-risk medical device issues. Calyxo had previously redesigned the CVAC system, securing 510(k) clearance in 2023, following real-world experience with an earlier version cleared in 2020.

24-03-2025

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