CVAC Aspiration System (Calyxo) – Labeling Update (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

On 2/19/2025, correction notices were mailed to distributors and healthcare providers who were asked to do the following: 1) Notify all urologists utilizing the affected aspiration system in your institution that additional instructions are required. Please provide each of them with a copy of the additional instructions. 2) As another safety step, a firm representative will be contacting all users from your institution directly to offer training on these additional instructions. If you prefer to coordinate the training, please specifically state that preference in the acknowledgement. 3) Please acknowledge receipt of the notice, additional instructions, and updated training instructions MA00100.A by emailing qualitycontrol@calyxoinc.com, or calling 833-214-3354 and providing your name, title, institution and address.