FDA Medical Device Recalls (openFDA)
Calyxo, Inc.: CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.
- Recall number
- Z-1396-2025
- 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.
- Status
- Open, Classified
- Initiated
- 2025-02-19
- Posted
- 2025-03-21
- Terminated
- not on file
- Reason
- 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
- 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 qualitycontrol@calyxoinc.com, or calling 833-214-3354 and providing your name, title, institution and address.
- Quantity
- 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.
- Lot, serial or model codes
- CVC127020-1 UDI-DI: 00860005357710, L00018 Rev C
- 510(k) numbers
- ["K233472"]
- PMA numbers
- not on file
- Product code
- FED
- Firm FEI
- 3014683069
- Firm city
- Pleasanton
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28