San Diego, CA, United States
Volcano Corp recalls
10 recalls recorded since 2018, most recently on 6 August 2026. 6 are listed as ongoing. Status and classification are as published by the FDA.
Recalls10
Ongoing (FDA)6
Terminated or completed4
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 6 August 2026
- Reason
- Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
- Distribution
- Worldwide - US Nationwide distribution in the states of MA, MN, TX, AL, GA, CA and the countries of Belgium, Denmark, Germany, Netherlands, Poland, Spain, Sweden, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3276-2026
- Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Ongoing Class II Medical devices
- Recall started
- 13 June 2025
- Reason
- 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"
- 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, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2221-2025
- 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.
Terminated Class II Medical devices
- Recall started
- 16 May 2022
- Terminated
- 23 December 2024
- Reason
- Due to a potential failed sterilization process.
- Distribution
- U.S.: WA and WI O.U.S.: Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1270-2022
- Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Ongoing Class III Medical devices
- Recall started
- 13 May 2022
- Reason
- Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
- 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, F
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1301-2022, Z-1302-2022
- Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
- Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
Ongoing Class III Medical devices
- Recall started
- 3 February 2022
- Reason
- 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.
- 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, DC, WA, KS, NE, ND, CT, VT. OUS: SK, IT, DK, GB, DE, SE, IN, KW, QA, PL, NL, CL, JP, BE, AU, FR, PF, PT, NZ, CA, ES, PK, CY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0917-2022
- MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems
Ongoing Class III Medical devices
- Recall started
- 24 January 2022
- Reason
- 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, and Model Reference Information.
- Distribution
- US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0901-2022
- IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Ongoing Class II Medical devices
- Recall started
- 19 January 2022
- Reason
- If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed, that may cause users to mistakenly use incorrect measurements, leading to inappropriate patient treatment. Image acquisition and processing system operators manual to be updated to include workflow alternatives.
- Distribution
- US: WI, CA, CO, MO, ID, DC, LA, VA, KS, OK, GA, KY, IL, AZ, NY, IN, FL, TX, NC, OH, WA, OR, NM, MT, IA, MI, TN, MN, PA, AL, MA, WV, NV, NH, CT, NE, NJ, HI, AR, UT, MD, SC, MS, AK, DE OUS: JP, SA, GB, DE, PT, SG, PL, ZA, NL, MT, ES, IN, GR, EG, FI, HK, FR, NO, DK, BE, AT, IT, CO, KW, MX, PS, QA, C
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0885-2022
- SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Terminated Class II Medical devices
- Recall started
- 7 November 2018
- Terminated
- 14 July 2022
- Reason
- Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS).
- Distribution
- Distribution was nationwide. There was government/military distribution. Foreign distribution was made to Canada, Austria, Australia, Badajoz, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong K
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0674-2020
- Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano Imaging System s5i, Part #807400001; (2) s5ix Imaging System w
Terminated Class II Medical devices
- Recall started
- 17 October 2018
- Terminated
- 30 April 2021
- Reason
- Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter.
- Distribution
- Worldwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0726-2019, Z-0727-2019
- Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer
- Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer
Terminated Class II Medical devices
- Recall started
- 22 March 2018
- Terminated
- 28 April 2021
- Reason
- The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.
- Distribution
- Worldwide Distribution -- U.S., to the states of California, Connecticut, Tennessee, North Carolina, Maryland, and Oregon; and, the country of Australia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1891-2018
- Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.