medical MODERATE Updated 2025-08-06

Volcano Corp recalls Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), R

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Recalled 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.

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Hazard / Issue

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"

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00845225002848, 00184360000037. Instructions for use: 300004875732_A Revision Date: 03/2021, 300004410212.A Release Date: 03/2021

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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