Reported Aug 6, 2025 · Ongoing
Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700,…
Volcano Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Volcano Corp · 3721 Valley Centre Dr Ste 500 · San Diego, CA · 92130-3328
Is this the product you have?
- Volcano Visions Digital IVUS CatheterPV.014P (Platinum)
- REF
85910PPV.014P RX
- REF
014Rand PV.018
- REF
8670086700J used with Instructions for use
- Lot codes and dates
- UDI-DI
0084522500284800184360000037
- Instructions for use300004875732_A
- Revision Date
03/2021300004410212
- A Release Date03/2021
- UDI-DI
- Amount recalled
- 233,817
Where it was sold
Why it was recalled
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"
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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