--- title: "Volcano Corp Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Volcano Corp recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/volcano-corp/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Volcano Corp recall records **5** reported ongoing 6 records in this archive. Latest source date Jun 13, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jun 13, 2025 FDA device enforcement ### [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.](https://isitonrecall.com/recall/fda-device-z-2221-2025-volcano-visions-digital-ivus-catheter-pv-014p-platinum-ref-85910p-pv-014p-rx-ref-014r-and-pv-018-ref/) 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 instructio... Class II Reported ongoing 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... [Official source for Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2221-2025%22) May 16, 2022 FDA device enforcement ### [Philips OmniWire Pressure guide wire REF 89185J PN 300000252891](https://isitonrecall.com/recall/fda-device-z-1270-2022-philips-omniwire-pressure-guide-wire-ref-89185j-pn-300000252891/) Due to a potential failed sterilization process. Class II Reported terminated Distribution: U.S.: WA and WI O.U.S.: Canada [Official source for Philips OmniWire Pressure guide wire REF 89185J PN 300000252891](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1270-2022%22) May 13, 2022 FDA device enforcement ### [Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797](https://isitonrecall.com/recall/fda-device-z-1301-2022-volcano-visions-pv-035-digital-ivus-catheter-ref-88901-pn-300005384002-rx-only-sterile-eo-ce-2797/) Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications Class III Reported 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, ... [Official source for Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1301-2022%22) May 13, 2022 FDA device enforcement ### [Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797](https://isitonrecall.com/recall/fda-device-z-1302-2022-volcano-visions-pv-035-digital-ivus-catheter-ref-81234-pn-300007367341-rx-only-sterile-eo-ce-2797/) Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications Class III Reported 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, ... [Official source for Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1302-2022%22) Feb 3, 2022 FDA device enforcement ### [MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems](https://isitonrecall.com/recall/fda-device-z-0917-2022-mm-tsm-touch-screen-module-secondary-controller-bedside-controller-part-numbers-300002018101-3000020/) Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will be replaced with full protective metal... Class III Reported ongoing Distribution: US: AZ, IL, NV, MI, FL, NC, AK, PA, WI, MN, CA, AR, NJ, TX, OR, NM, SD, CO, KY, LA, DE, MA, MT, MO, VA, AL, NY, WV, SC, IN, GA, IA, OH, UT, NH, MS, TN, OK, ID, MD, HI, RI, WY, D... [Official source for MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101,...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0917-2022%22) Jan 24, 2022 FDA device enforcement ### [IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102](https://isitonrecall.com/recall/fda-device-z-0901-2022-intrasight-mobile-ivus-systems-model-797415-part-numbers-300002018101-300002018102/) Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, a... Class III Reported ongoing Distribution: US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT [Official source for IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0901-2022%22) ## Reasons in these listed records - 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 addin... - Due to a potential failed sterilization process. - Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications - Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will be replaced with full protective metal brackets. These examples come from this result page and are not a ranking of every recall reason. ## Checking Volcano Corp ### Is there a recall on volcano corp right now? This archive contains 6 records, including 5 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Volcano Corp](https://isitonrecall.com/check/?q=Volcano%20Corp) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)