Calyxo recalls CVAC Aspiration System for endoscopic kidney procedures due to potential kidney pressure imbalance if fluid inflow continues without proper outflow.
Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidney, not to continue providing fluid inflow in the presence of unresolved slow or absent fluid outflow because this can create intrarenal pressure imbalance, and lead to excessive intrarenal pressure.
Calyxo is recalling its CVAC Aspiration System for endoscopic kidney procedures. The device could cause dangerous kidney pressure imbalances if fluid inflow continues when outflow is slow or absent, which might lead to serious complications.
The device can create dangerous pressure imbalances in the kidney if fluid inflow continues when outflow is slow or absent. This happens because the system is designed for endoscopic procedures on the urinary tract and kidney interior, and improper use with high viscosity fluids can lead to excessive pressure.
Healthcare professionals using the CVAC Aspiration System for kidney procedures are most at risk. Patients with high viscosity fluid in the kidney may experience complications if the device is used incorrectly.
Check for the CVAC Aspiration System with reference number CVC127020-1 or user manual L00018. The product was sold for endoscopic kidney procedures.
Look for the reference number CVC127020-1 or user manual L00018 on the device.
The recall is for potential risks when the device is used incorrectly, not for normal use with proper instructions.
The official recall does not specify a remedy, so contact Calyxo directly for guidance.
The recall states that improper use could lead to excessive intrarenal pressure, which might cause serious complications.
We’ve drafted a message you can send Calyxo to request your refund or repair — edit it as you like.
Subject: Recall Z-1396-2025 — Calyxo Calyxo Hello, I own a Calyxo that is covered by recall Z-1396-2025 from Calyxo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
