Volcano Recalls
31 recalls on record · September 19, 2012 to August 6, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 6, 2025Medical DevicesFDA
Volcano Corp recalls Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 8
Hazard: 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"
July 6, 2022Medical DevicesFDA
Volcano Corp recalls Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
Hazard: Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
July 6, 2022Medical DevicesFDA
Volcano Corp recalls Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Hazard: Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
June 22, 2022Medical DevicesFDA
Volcano Corp recalls Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Hazard: Due to a potential failed sterilization process.
April 20, 2022Medical DevicesFDA
Volcano Corp recalls MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used wit
Hazard: 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.
April 20, 2022Medical DevicesFDA
Volcano Corp recalls IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Hazard: 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.
April 13, 2022Medical DevicesFDA
Volcano Corporation recalls SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Hazard: 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.
December 18, 2019Medical DevicesFDA
Volcano Corporation recalls Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper H
Hazard: Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS).
January 23, 2019Medical DevicesFDA
Volcano Corporation recalls Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usage: The Volcano PV .
Hazard: 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.
January 23, 2019Medical DevicesFDA
Volcano Corporation recalls Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .
Hazard: 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.
May 23, 2018Medical DevicesFDA
Volcano Corporation recalls Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evalu
Hazard: The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.
December 6, 2017Medical DevicesFDA
Volcano Corporation recalls Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System
Hazard: On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during use, and the users response to the dialog may adversely affect the subsequent operation of the device.
April 19, 2017Medical DevicesFDA
Volcano Corporation recalls Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.273; Catalog number 89
Hazard: High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of imaging.
April 19, 2017Medical DevicesFDA
Volcano Corporation recalls Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number 89800.
Hazard: High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of imaging.
June 1, 2016Medical DevicesFDA
Volcano Corporation recalls Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volca
Hazard: Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from the hospital network and be forced to reboot
March 9, 2016Medical DevicesFDA
Volcano Corporation recalls Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to
Hazard: Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.
March 9, 2016Medical DevicesFDA
Volcano Corporation recalls Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover
Hazard: Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.
September 9, 2015Medical DevicesFDA
Volcano Corporation recalls Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular
Hazard: Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the Pioneer Plus intravascular Ultrasound Guided Re-Entry Catheters.
July 29, 2015Medical DevicesFDA
Volcano Corporation recalls Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technolog
Hazard: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
July 29, 2015Medical DevicesFDA
Volcano Corporation recalls Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technolog
Hazard: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
July 29, 2015Medical DevicesFDA
Volcano Corporation recalls Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technolog
Hazard: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
July 29, 2015Medical DevicesFDA
Volcano Corporation recalls Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technolog
Hazard: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
July 29, 2015Medical DevicesFDA
Volcano Corporation recalls Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technolog
Hazard: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
July 29, 2015Medical DevicesFDA
Volcano Corporation recalls Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Tech
Hazard: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
July 15, 2015Medical DevicesFDA
Volcano Corp recalls ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-001. Intravascular Imag
Hazard: A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output.
July 15, 2015Medical DevicesFDA
Volcano Corp recalls Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020
Hazard: A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output.
July 15, 2015Medical DevicesFDA
Volcano Corp recalls Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 a
Hazard: A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output.
July 1, 2015Medical DevicesFDA
Volcano Corporation recalls Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measur
Hazard: During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
July 1, 2015Medical DevicesFDA
Volcano Corporation recalls Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evalua
Hazard: During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
September 24, 2014Medical DevicesFDA
Volcano Corporation recalls Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move t
Hazard: Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.