FDA Medical devices recall ·
CVAC Aspiration System recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1396-2025
- Date
- (initiated February 19, 2025)
- Company / brand
- Calyxo, Inc.
4473 Willow Rd, Pleasanton, CA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 11,246
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
CVC127020-1 UDI-DI: 00860005357710, L00018 Rev C
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.
States: Alabama Arizona California Colorado Connecticut Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada Ohio Oklahoma Oregon Pennsylvania South Carolina Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1396-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.