The Recall Desk

Manufacturer

Volcano Corp

9 recalls in our database name Volcano Corp as the manufacturing or recalling firm.

What the numbers show

Total
9
Critical
0
Severe
0
Most recent
2025-08-06

Of the 9 recalls from Volcano Corp we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

  • HighFDA (Devices)·Z-2221-2025·2025-08-06

    Volcano Visions IVUS catheters can entangle with the guide wire

    Volcano Visions Digital IVUS Catheters are being recalled following reports of catheter and guide wire entanglement during radial-to-peripheral procedures, which may require surgical removal. 233,817 units affected.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1301-2022·2022-07-06

    IVUS Catheter Recall: Missing Contraindications in Instructions

    Volcano Corp is recalling Visions PV. 035 Digital IVUS Catheters because instructions for use do not include contraindications information. Healthcare providers should contact the manufacturer for complete safety documentation before use.

    Product
    Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1302-2022·2022-07-06

    Digital IVUS Catheter Recalled for Missing Contraindication Information

    Volcano Corp is recalling 7,520 units of the Volcano Visions PV. 035 Digital IVUS Catheter due to missing contraindication information in the instructions for use. The IFU lacks details about situations where the device should not be used.

    Product
    Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1270-2022·2022-06-22

    Philips OmniWire guide wire recalled for potential sterilization failure

    Volcano Corp is recalling 11 Philips OmniWire Pressure guide wires distributed in Washington, Wisconsin, and Canada due to a potential failed sterilization process.

    Product
    Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0917-2022·2022-04-20

    FDA Recalls Touch Screen Modules for IVUS Imaging Systems

    Volcano Corp is recalling MM-TSM touch screen modules used with IntraSight Integrated IVUS systems because they may crack or become damaged, potentially rendering the imaging equipment non-functional.

    Product
    MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems
    Category
    Medical Device
    Distribution
    50 states
  • LowFDA (Devices)·Z-0901-2022·2022-04-20

    IntraSight Mobile IVUS touch screen modules missing required labeling information

    IntraSight Mobile IVUS Systems touch screen modules lack required labeling information including device identifier and manufacturer information. Affected units were distributed to healthcare facilities in the US and internationally.

    Product
    IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2045-2015·2015-07-15

    Volcano ComboMap Intravascular System Recalled for Interoperability Limitation

    Volcano Corp is recalling 227 ComboMap Intravascular Flow and Pressure Systems due to a limitation in interoperability with the Philips Xper Flex Cardia Physiomonitoring System.

    Product
    ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-001. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2043-2015·2015-07-15

    Volcano Intravascular Ultrasound System Recalled for Interoperability Limitation

    Volcano Corp is recalling 227 intravascular ultrasound systems due to a limitation that may affect Fraction Flow Reserve calculations when connected to specific Philips monitors.

    Product
    Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE MOBILE - 400-0100.01. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2044-2015·2015-07-15

    Volcano Intravascular Ultrasound System Recalled for Interoperability Limitation

    Volcano Corp is recalling 227 Intravascular Ultrasound Imaging and Pressure Systems due to a limitation in interoperability with the Philips Xper Flex Cardia system that may impact Fraction Flow Reserve calculations.

    Product
    Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structu
    Category
    Medical Device
    Distribution
    Distributed nationwide