Use cautionMedical device recall · FDA · Published June 13, 2025
Volcano Visions Digital IVUS Catheter Recall: Entanglement Risk During Procedures
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"
Take action
Contact the company
📍Recalling firmVolcano Corp3721 Valley Centre Dr Ste 500 · San Diego, CA 92130-3328
“Volcano Visions Digital IVUS Catheter Recall: Entanglement Risk During Procedures.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52043-volcano-visions-digital-ivus-catheter-recall-entanglement-risk-during-procedures. Based on FDA recall #Z-2221-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2221-2025%22&limit=1).
The FDA announced on June 13, 2025, that Volcano Corp is recalling Volcano Visions Digital IVUS Catheters due to entanglement hazards during use. The agency classified the recall as Class II and ongoing.
How to tell if you have it
Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P
PV.014P RX, REF: 014R
PV.018, REF: 86700
The hazard
The FDA reported that IVUS catheters and guide wires may become entangled during radial-to-peripheral procedures if used without the appropriate sheath or guide catheter. This entanglement may require further intervention, such as surgical removal.
Context
GovInfoNow's records show Volcano Corp has issued five other recalls since January 24, 2022. On August 6, 2026, the company recalled Philips IntraSight Plus devices due to software errors that could associate patient data incorrectly. Other recent recalls of similar products include Elekta Geneva Brachytherapy Applicator Recall (April 3, 2026), Medline Urethral Catheter Tray Recall (May 4, 2026), and Medline Medical Procedure Kits Recall (May 4, 2026).
How to tell if you have this one
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.
Brand
Volcano Corp
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Instructions for Use
Verify the product's instructions for use to ensure it matches the recall details.
Use Appropriate Sheath
Always use a guide sheath of the correct length to prevent entanglement during procedures.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 54 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2221-2025 (June 13, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2221-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.