CVAC Aspiration System Requires Labeling Update for Pressure Risk
The CVAC Aspiration System requires a labeling update to add safety instructions for high-viscosity kidney fluid. Continuing fluid inflow without adequate outflow can create dangerous intrarenal pressure imbalances.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is classified as FDA Class I, which mandates a minimum severity score of 4. The recall addresses critical labeling deficiencies related to intrarenal pressure risks during endoscopic procedures.
Plain-English summary
The FDA is recalling the CVAC Aspiration System (REF: CVC127020-1), a medical device for endoscopic examination and treatment of the urinary tract and kidney interior, due to incomplete labeling. Manufacturer Calyxo, Inc. has issued a Class I recall requiring labeling updates.
The device labeling must be updated to include specific instructions for use with patients who have high-viscosity kidney fluid. Users must not continue fluid inflow when fluid outflow is slow or absent, as this can cause intrarenal pressure imbalance and excessive intrarenal pressure.
The recall affects 11,246 units distributed nationwide. Healthcare facilities should obtain the updated labeling and ensure clinical staff review the new instructions before use.
The recalled product
- Product
- CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.
- Manufacturer
- Calyxo, Inc.
- Category
- Medical Device — Endoscopic
- Affected units
- 11,246
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- CVC127020-1 UDI-DI: 00860005357710
- L00018 Rev C
Distribution
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