Calyxo Medical has issued an urgent update regarding the safe use of its CVAC Aspiration Systems. Health care providers and regulatory compliance teams need to take immediate note of this change to ensure patient safety. The updates involve modifications to the system’s usage instructions and heightened warnings for specific clinical scenarios.
What changed?
As of February 19, 2025, Calyxo alerted relevant health care providers via an Urgent Device Field Correction notice. This action was prompted by new risks associated with the CVAC Aspiration System during procedures involving thick (high-viscosity) fluid within the kidney. Failure to properly address this clinical condition may result in reduced fluid outflow, excessive intrarenal pressure, and potential serious injury or death.
The FDA has classified this update as a Class I recall, the highest level of concern, underscoring the need for health care professionals to review and adopt the updated instructions immediately.
Who is affected?
The CVAC Aspiration System is used in endoscopic urological procedures for removing urinary stones. Facilities, surgeons, and urologists relying on these devices must immediately follow the actions outlined in the updated instructions to avoid adverse clinical outcomes. Per the manufacturer, these changes do not involve a withdrawal of the device from the market, but they are critical for the safe use of the equipment in specific patient populations.
Key safety guidelines
The updated instructions focus on proper monitoring and handling of fluid dynamics during procedures. Key recommendations include:
- Avoid continuing fluid inflow when faced with unresolved slow or absent fluid outflow, as this can cause a dangerous pressure imbalance in the kidney.
- Stop irrigation immediately if thick (high-viscosity) fluid or cloudy, turbid fluid is observed in the kidney’s collecting system.
- Discontinue use of the CVAC Aspiration System if visibility within the collecting system is fully obscured by opaque fluid to prevent potential complications.
- Contraindications remain for diagnostic or therapeutic ureteroscopy in patients with untreated urinary tract infection or significant comorbidities, such as coagulation disorders, severe cardiopulmonary issues, or uncontrolled diabetes.
- Ensure compatibility and proper setup of Ureteral Access Sheaths during use. Proper fluid monitoring is essential, particularly when 12/14 Fr Ureteral Access Sheaths are employed, as they may limit fluid outflow.
The manufacturer emphasizes following these updated instructions during all relevant procedures to mitigate risks.
FDA assessment and findings
As part of its evaluation, the FDA has confirmed Calyxo’s reporting of one death associated with the identified risk. This underscores the importance of adhering to the updated instructions outlined in this recall communication. Following these guidelines will play a critical role in reducing potential harm and ensuring the safe performance of the device.
Recommended actions
Calyxo urges all affected institutions to notify and educate medical professionals performing urological procedures using the CVAC Aspiration System about these updated safety measures. Specifically, organizations should confirm that:
- All clinicians and staff are aware of and trained on the new safety instructions.
- Equipment is set up to monitor fluid outflow at all times during procedures.
- Adherence to contraindications and proper sheath selection is maintained to avoid unnecessary complications.
Health care providers in the U.S. with questions about this correction should contact Calyxo via email at qualitycontrol@calyxoinc.com or by phone at 833-214-3354. Adverse reactions or quality problems can also be reported to MedWatch, the FDA Safety Information and Adverse Event Reporting Program.
Conclusion
The updated safety instructions for Calyxo CVAC Aspiration Systems are designed to address critical risks associated with its use in specific clinical settings. Health care professionals are strongly advised to review and implement these updates promptly. By doing so, they can avoid adverse events and ensure patient safety.
Disclaimer
This article is intended for informational purposes and is not a substitute for legal or regulatory advice. Health care professionals should consult official FDA and manufacturer communications for full guidance.
Mandatory FDA Line
For full information about the FDA announcement, see the link below.