Volcano Corp recalls specific IVUS catheter models due to entanglement risks during radial-to-peripheral procedures, requiring proper sheath use to prevent complications.
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"
Volcano Corp is recalling three IVUS catheter models because they can become entangled during certain medical procedures if used without the correct sheath. This may require additional medical intervention, such as surgery.
The catheters can become entangled during procedures when used without an appropriate sheath or guide catheter. This entanglement may require additional medical intervention, such as surgical removal.
Healthcare professionals using these catheters for radial-to-peripheral procedures are most at risk. Patients undergoing these procedures may also be affected if the catheter becomes entangled.
Check for the model numbers PV.014P (Platinum), PV.014P RX, or PV.018 with reference numbers 85910P, 014R, or 86700/86700J. These catheters were sold with specific instructions for use from March 2021.
Verify the product's instructions for use to ensure it matches the recall details.
Always use a guide sheath of the correct length to prevent entanglement during procedures.
The catheter can become entangled during radial-to-peripheral procedures if used without an appropriate sheath or guide catheter, potentially requiring surgical intervention.
The affected models are PV.014P (Platinum) with reference 85910P, PV.014P RX with reference 014R, and PV.018 with reference 86700 or 86700J.
No, but you must use a guide sheath of appropriate length to prevent entanglement during procedures.
We’ve drafted a message you can send Volcano Corp to request your refund or repair — edit it as you like.
Subject: Recall Z-2221-2025 — Volcano Corp Volcano Corp Hello, I own a Volcano Corp that is covered by recall Z-2221-2025 from Volcano Corp. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
