Recall Z-2221-2025— Volcano Corp
Class II · Ongoing
Class II FDA medical device recall by Volcano Corp, initiated 2025-06-13. It names 2 FDA 510(k) clearances: K152829, K150442. 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".
- Recalling firm
- Volcano Corp
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-13
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K152829 — Visions PV.014P RX Digital IVUS Catheter
- K150442 — Volcano Visions PV .018 Digital IVUS Catheter
K-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
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 for recall
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"
Data sourced from openFDA. This site is unofficial and independent of the FDA.