FDA Device recall Z-1396-2025
CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018
- FDA Device
- Class I
- ongoing
- Published 2025-04-02
On 2025-04-02 the FDA classified a Class I recall of CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018 by Calyxo, citing aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscos….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1396-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-02-19 |
| Published | 2025-04-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Calyxo |
| Distribution | US |
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.
Identifiers
| code_info | CVC127020-1 UDI-DI: 00860005357710, L00018 Rev C |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1396-2025%22
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