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The FDA is aware that Calyxo has issued a letter to affected customers indicating CVAC Aspiration Systems have updated instructions for use:
- CVAC Aspiration System
- Calyxo REF Number CVC127020-1 and User Manual L00018 Rev C
- UDI-DI: 00860005357710
Calyxo has identified a new risk of injury during use of the CVAC Aspiration System when patients have thick (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, serious injury or death may occur. Calyxo has reported 1 death associated with this issue.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Calyxo at qualitycontrol@calyxoinc.com or 833-214-3354.
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