FDA Device recall Z-2221-2025
Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P
- FDA Device
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P by Volcano, citing reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may requir….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2221-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-13 |
| Published | 2025-08-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Volcano |
| Distribution | US |
Product
Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.
Reason
Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical removal; Firm is restating instructions for use and adding: "Use a guide sheath of appropriate length to provide adequate support to the rapid exchange IVUS catheter and guidewire"
Identifiers
| code_info | UDI-DI: 00845225002848, 00184360000037. Instructions for use: 300004875732_A Revision Date: 03/2021, 300004410212.A Release Date: 03/2021 |
|---|
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-2221-2025%22
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