Volcano recalls
Volcano appears in 32 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-07.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 32 |
|---|---|
| Published | 2012-09-19 to 2026-10-07 |
| By agency | FDA Device (32) |
| By classification | Class II (28), Class III (4) |
| By status | terminated (25), ongoing (7) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
FDA Device · Class II · 2026-10-07 · Volcano
Reason: Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment. - Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P
FDA Device · Class II · 2025-08-06 · Volcano
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… - Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
FDA Device · Class III · 2022-07-06 · Volcano
Reason: Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications - Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
FDA Device · Class III · 2022-07-06 · Volcano
Reason: Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications - Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
FDA Device · Class II · 2022-06-22 · Volcano
Reason: Due to a potential failed sterilization process. - IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
FDA Device · Class III · 2022-04-20 · Volcano
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… - MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integr…
FDA Device · Class III · 2022-04-20 · Volcano
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… - SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
FDA Device · Class II · 2022-04-13 · Volcano
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 mistake… - Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems…
FDA Device · Class II · 2019-12-18 · Volcano
Reason: Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS). - Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usage: The Volcano PV .035 Digital IVUS Cathet…
FDA Device · Class II · 2019-01-23 · Volcano
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. - Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035 Digital IVUS Cathet…
FDA Device · Class II · 2019-01-23 · Volcano
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. - Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only
FDA Device · Class II · 2018-05-23 · Volcano
Reason: The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image. - Volcano Imaging System s5i REF 807400001
FDA Device · Class II · 2017-12-06 · Volcano
Reason: 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. - Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter
FDA Device · Class II · 2017-04-19 · Volcano
Reason: 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. - Refinity Rotational Intravascular Ultrasound (IVUS) Catheter
FDA Device · Class II · 2017-04-19 · Volcano
Reason: 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. - Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits
FDA Device · Class II · 2016-06-01 · Volcano
Reason: 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 for… - Volcano SpinVision Sterile Equip cover II
FDA Device · Class II · 2016-03-09 · Volcano
Reason: 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 ex… - Volcano R100 Sterile Equipment Cover
FDA Device · Class II · 2016-03-09 · Volcano
Reason: 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 ex… - Volcano Pioneer Plus Re-Entry Catheter
FDA Device · Class II · 2015-09-09 · Volcano
Reason: 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. - Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 softwa…
FDA Device · Class II · 2015-07-29 · Volcano
Reason: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. - Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 softwa…
FDA Device · Class II · 2015-07-29 · Volcano
Reason: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. - Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 softwa…
FDA Device · Class II · 2015-07-29 · Volcano
Reason: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. - Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 softwa…
FDA Device · Class II · 2015-07-29 · Volcano
Reason: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. - Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 s…
FDA Device · Class II · 2015-07-29 · Volcano
Reason: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. - Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 softwa…
FDA Device · Class II · 2015-07-29 · Volcano
Reason: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. - ComboMap Intravascular Flow and Pressure System
FDA Device · Class II · 2015-07-15 · Volcano
Reason: 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) wi… - Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System
FDA Device · Class II · 2015-07-15 · Volcano
Reason: 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) wi… - Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System
FDA Device · Class II · 2015-07-15 · Volcano
Reason: 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) wi… - Prestige Plus 185cm J-Tip: Part number: 9185J
FDA Device · Class II · 2015-07-01 · Volcano
Reason: 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… - Volcano PV .035 Catheter: Part number: 88901
FDA Device · Class II · 2015-07-01 · Volcano
Reason: 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… - Volcano TrakBack II Disposable Pullback Device
FDA Device · Class II · 2014-09-24 · Volcano
Reason: Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product. - Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.0…
FDA Device · Class II · 2012-09-19 · Volcano
Reason: The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself.