Z-1396-2025Class I

CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic...

Name: Z-1396-2025 CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic...
Creator: Calyxo, Inc.
Published: 2025-02-19
License: https://open.fda.gov/license/

Calyxo, Inc. / initiated 2025-02-19 / Open, Classified / root cause: design

FDA source

Calyxo, Inc. began a recall of CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior on 2025-02-19. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1396-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-02-19
Posted: 2025-03-21
Recalling firm: Calyxo, Inc.
Product: CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.
Product code: FED Endoscopic Access Overtube, Gastroenterology-Urology
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 11,246
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 codes and lots: CVC127020-1 UDI-DI: 00860005357710, L00018 Rev C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1396-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1396-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-21

Product code FED

K233472Class IICVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. / cleared 2024-02-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)