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Lower risk Medical device recall · FDA · Published May 13, 2022

Volcano Visions PV.035 Digital IVUS Catheter Recall: Missing Contraindications

Volcano Corp recalls specific digital IVUS catheters due to missing contraindications in instructions. Affected units have IFU part number 300004856772/A with revision date 05/2021. Consumers should check their catheter labels for the UDI/DI code 00845225002329.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1301-2022Medical deviceVolcano Corp ›
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Contact the company

Recalling firmVolcano Corp3721 Valley Centre Dr Ste 500 · San Diego, CA 92130-3328
✎ GovInfoNow plain-language explainer

Volcano Corp is recalling certain digital IVUS catheters because their instructions for use do not include contraindications. This means users might not be aware of conditions where the catheter should not be used, potentially leading to unsafe medical procedures. Read more at govinfonow.com/recall/60702-volcano-visions-pv-035-digital-ivus-catheter-recall-missing-contraindications.

Source Summary by GovInfoNow · govinfonow.com/recall/60702-volcano-visions-pv-035-digital-ivus-catheter-recall-missing-contraindications · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1301-2022

Cite this page

“Volcano Visions PV.035 Digital IVUS Catheter Recall: Missing Contraindications.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60702-volcano-visions-pv-035-digital-ivus-catheter-recall-missing-contraindications. Based on FDA recall #Z-1301-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1301-2022%22&limit=1).

The FDA announced on May 13, 2022, that Volcano Corp is recalling its Volcano Visions PV. 035 Digital IVUS Catheter because the instructions for use lack required contraindications. The agency issued recall number Z-1301-2022 for the Class III device.

How to tell if you have it

  • Brand: Volcano Corp
  • Product: Volcano Visions PV. 035 Digital IVUS Catheter
  • REF: 88901
  • PN: 300005384002
  • IFU Part Number: 300004856772/A
  • Revision Date: 05/2021
  • UDI/DI: 00845225002329

The hazard

The digital IVUS catheter instructions for use do not contain contraindications, according to the FDA. The recall involves 14,031 units distributed worldwide and in U.S. states including NY, CA, AZ, LA, NV, AL, MI, WI, CO, TX, NJ, OR, FL, KS, IL, MD, PA, OH, NC, OK, MN, AK, GA, MO, SC, MS, KY, AR, VA, SD, TN, MA, DE, NE, MT, CT, WV, WA, IN, IA, HI, NH, WY, UT, ID, DC, RI, NM, ME, VT.

Context

GovInfoNow's records show Volcano Corp has had five other recalls since January 24, 2022. On June 13, 2025, the company recalled a digital IVUS catheter due to entanglement risks during procedures. Other recent recalls of similar products include Philips IntraSight Plus Software Error (August 6, 2026), Philips OmniWire Pressure Guide Wire (May 16, 2022), Stryker CS Uni-Directional w Auto ID Catheter (April 10, 2026), Paradise Ultrasound Renal Denervation Catheter (January 29, 2026), and Stryker Daig Livewire Steerable Catheter (April 10, 2026).

How to tell if you have this one

Check the catheter's label for the IFU part number 300004856772/A with a revision date of 05/2021. The unique device identifier (UDI/DI) should be 00845225002329.

  • Brand
    Volcano Corp
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class III
  • Status
    Ongoing
  • Distribution
    Worldwide distribution - US Nationwide distribution in the states of NY, CA, AZ, LA, NV, AL, MI, WI, CO, TX, NJ, OR, FL, KS, IL, MD, PA, OH, NC, OK, MN, AK, GA, MO, SC, MS, KY, AR, VA, SD, TN, MA, DE, NE, MT, CT, WV, WA, IN, IA, HI, NH, WY, UT, ID, DC, RI, NM, ME, VT and the countries of ES, SE, FR, PR, IT, DE, CA, NZ, PL, BR, ZA, NL.
Recall numberProduct, codes & lotsQuantity
Z-1301-2022Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797; All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 , ; UDI/DI: 0084522500232914.031 units
Z-1302-2022Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797; All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 ,; UDI/DI: 008452250025967,520 units
Based on the official FDA remedy

What to do — step by step

  1. Check Your Catheter Label

    Look for the IFU part number 300004856772/A with revision date 05/2021 and UDI/DI code 00845225002329.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 49 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of NY, CA, AZ, LA, NV, AL, MI, WI, CO, TX, NJ, OR, FL, KS, IL, MD, PA, OH, NC, OK, MN, AK, GA, MO, SC, MS, KY, AR, VA, SD, TN, MA, DE, NE, MT, CT, WV, WA, IN, IA, HI, NH,…” 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, 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.

1. Firm started the recall: May 13, 202212. FDA classified it Class III: Jun 29, 202223. Published in FDA’s Enforcement Report: Jul 6, 202232022
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using this catheter?

No, the recall does not require stopping use immediately. However, healthcare professionals should verify the catheter's label to confirm it is affected.

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Where this comes from

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-1301-2022 (May 13, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1301-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA