Recall Z-1396-2025— Calyxo, Inc.
Class I · Ongoing
Class I FDA medical device recall by Calyxo, Inc., initiated 2025-02-19. It names one FDA 510(k) clearance: K233472. Product: CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.. 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..
- Recalling firm
- Calyxo, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-02-19
- Firm location
- Pleasanton, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.