Calyxo, Inc.: Device Recall

Recall #Z-1396-2025 · 02/19/2025

Class I: Dangerous

Recall Details

Recall Number: Z-1396-2025
Classification: Class I
Product Type: Device
Recalling Firm: Calyxo, Inc.
Status: Ongoing
Date Initiated: 02/19/2025
Location: Pleasanton, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 11,246

Reason for Recall

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.

Product Description

CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.

Distribution Pattern

US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.