CVAC Aspiration System, REF: CVC127020-1, and User Manual… recallZ-1396-2025 · Calyxo, Inc. · initiated Feb 19, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Calyxo, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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 [email protected], or calling 833-214-3354 and providing your name, title, institution and address.
Recall details
- Recall number
- Z-1396-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 19, 2025
- Posted by the FDA
- Mar 21, 2025
- Recalling firm
- Calyxo, Inc.
- Quantity
- 11,246
- Product code
- FED
- FDA submissions
- K233472
- Distribution
- 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.
Product description
CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.
Code information (models, lots, serial numbers)
CVC127020-1 UDI-DI: 00860005357710, L00018 Rev C
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CVAC Aspiration System CVC127020-1Calyxo, Inc. · Ureteroscope And Accessories, Flexible/Rigid1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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