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VOLCANO CORPORATION

United States·US-MF-000020094

Last updated September 17, 2026

Information

Country: United States
Address: 3721, Valley Centre Drive, San Diego, United States
Website: n/a
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: n/a
PRRC Contact: Megan Olen
EUDAMED SRN: US-MF-000020094
FDA FEI Number: 3008363989
DUNS Number: 135179237

Catalogue (82)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Crux® Vena Cava FIlter, Femoral	7024	FDA UDI	Class II	Active
S5 Imaging System P/N 807300001	807300001	FDA UDI	Class II	Active
ComboMap Pressure and Flow System	6800	FDA UDI	Class II	Active
CORE Series Precision Guided Therapy System	S18081AA	FDA UDI	Class II	Active
SmartMap Pressure System	800573001-ROHS	FDA UDI	Class II	Active
s5i Imaging System Workstation	807401001	FDA UDI	Class II	Active
FloWire Doppler Guide Wire XT 300cm 014 ST	1413	FDA UDI	Class II	Active
Crux® Vena Cava FIlter, Jugular	7025	FDA UDI	Class II	Active
FloWire Doppler Guide Wire XT 300cm 014 JTIP	1413J	FDA UDI	Class II	Active
Core Fm System	400-0100.11	FDA UDI	Class II	Active
FloWire Doppler Guide Wire XT 175cm 014 JTIP	1403J	FDA UDI	Class II	Active
Digital IVUS Sterile Equipment Cover	5902VC	EUDAMEDFDA UDI	Class I	Active
Sync-Rx System	K132558	FDA 510(k)	Class II	Active
CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit	K172455	FDA 510(k)	Class II	Active
Volcano Preview Forward-Looking Ivus System	K132659	FDA 510(k)	Class II	Active
Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip	K161887	FDA 510(k)	Class II	Active
Volcano S5/S5i Intravascular Ultrasound Imaging And Pressure System	K123898	FDA 510(k)	Class II	Active
Valet Micro Catheter	K112035	FDA 510(k)	Class II	Active
Volcano S5 Imaging System, Model 804200-001	K051920	FDA 510(k)	Class II	Active
Volcano iFR Harvest Software (Offline)	K143122	FDA 510(k)	Class II	Active
In Vision Gold With Spin Vision, Model 891 Sv	K052348	FDA 510(k)	Class II	Active
Smartwire Pressure Guide Wire, Model 66xx	K070487	FDA 510(k)	Class II	Active
Volcano S5iintravascular Imaging And Pressure System	K111706	FDA 510(k)	Class II	Active
SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz	K153369	FDA 510(k)	Class II	Active
Revolution 45mhz Ivus Imaging Catheter	K080891	FDA 510(k)	Class II	Active
Crux Snare Filter Retrieval Set	K133681	FDA 510(k)	Class II	Active
Volcano S5/S5i Intravascular Imaging And Pressure System	K071554	FDA 510(k)	Class II	Active
Revolution 45 Mhz Rotational Ivus Imaging Catheter	K050995	FDA 510(k)	Class II	Active
s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System	K173860	FDA 510(k)	Class II	Active
Volcano Angio-Ivus Mapping (aim) System	K060483	FDA 510(k)	Class II	Active
Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus Imaging Catheter, Model 85700	K073473	FDA 510(k)	Class II	Active
Reflow Aspiration Catheter	K123482	FDA 510(k)	Class II	Active
Primewire Prestige Plus	K111395	FDA 510(k)	Class II	Active
Volcano S5i Intravascular Ultracound Imaging And Pressure System	K113486	FDA 510(k)	Class II	Active
Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859xx; Volcano Vh-Ivus System, Model 8049xx-001	K051337	FDA 510(k)	Class II	Active
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip	K192886	FDA 510(k)	Class II	Active
Visions Pv 8.2 Intravascular Ultrasound Imaging Catheter, Model 88900	K071660	FDA 510(k)	Class II	Active
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box	K152582	FDA 510(k)	Class II	Active
Primewire Prestiage Pressure Guide Wire, Models 8185, 8185j, 8300, 8300j	K100930	FDA 510(k)	Class II	Active
Volcano S51 Family Of Imaging Systems	K061215	FDA 510(k)	Class II	Active
Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular	K150262	FDA 510(k)	Class II	Active
Volcano iFR Modality, iFR Scout feature	K150441	FDA 510(k)	Class II	Active
Volcano Core Control Pad, Accessory To The Volcano S5/S5i Intravascular Ultrasound Imaging & Pressure Systems	K140291	FDA 510(k)	Class II	Active
Volcano Lomap, Volcano Lomap Option Kit For Mobile System, Volcano Lomap Option For Integrated System, Volcano S5 Precision	K133142	FDA 510(k)	Class II	Active
Core Control Pad, Core Series Sw V3.4 Installation Kit, Core, Core Mobile	K133641	FDA 510(k)	Class II	Active
Preview Forward-Looking Ivus Catheter And Laptop System; Preview Catheter Model 87000; Pimf Model 87-Pimf; Laptop System	K122826	FDA 510(k)	Class II	Active
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip	K202543	FDA 510(k)	Class II	Active
Volcano Ifr Modality	K133323	FDA 510(k)	Class II	Active
S5/S5i Series Intravascular Imaging And Pressure System, Combomap Pressure And Flow System	K082229	FDA 510(k)	Class II	Active
Verrata Pressure Guide Wire	10185J	EUDAMEDFDA UDI	Class III	Active

Related Companies

Authorised Representatives

Volcano Europe BE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

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FDA Recalls (36)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 13, 2025	Z-2221-2025	—	open, classified	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"
May 16, 2022	Z-1270-2022	—	terminated	Due to a potential failed sterilization process.
May 13, 2022	Z-1302-2022	—	open, classified	Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
May 13, 2022	Z-1301-2022	—	open, classified	Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Feb 3, 2022	Z-0917-2022	—	open, classified	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.
Jan 24, 2022	Z-0901-2022	—	open, classified	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.
Jan 19, 2022	Z-0885-2022	—	open, classified	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.
Nov 7, 2018	Z-0674-2020	—	terminated	Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS).
Oct 17, 2018	Z-0726-2019	—	terminated	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.
Oct 17, 2018	Z-0727-2019	—	terminated	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.
Mar 22, 2018	Z-1891-2018	—	terminated	The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.
Nov 3, 2017	Z-0189-2018	—	terminated	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.
Mar 29, 2017	Z-1776-2017	—	terminated	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.
Mar 29, 2017	Z-1775-2017	—	terminated	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.
Apr 25, 2016	Z-1813-2016	—	terminated	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
Feb 5, 2016	Z-1041-2016	—	terminated	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.
Feb 5, 2016	Z-1042-2016	—	terminated	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.
Jul 22, 2015	Z-2718-2015	—	terminated	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.
Jun 22, 2015	Z-2133-2015	—	terminated	A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Jun 22, 2015	Z-2134-2015	—	terminated	A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Jun 22, 2015	Z-2136-2015	—	terminated	A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Jun 22, 2015	Z-2135-2015	—	terminated	A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Jun 22, 2015	Z-2132-2015	—	terminated	A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Jun 22, 2015	Z-2131-2015	—	terminated	A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Jun 4, 2015	Z-1844-2015	—	terminated	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
Jun 4, 2015	Z-1845-2015	—	terminated	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
Aug 13, 2014	Z-2636-2014	—	terminated	Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
Sep 23, 2013	Z-2044-2015	—	terminated	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.
Sep 23, 2013	Z-2045-2015	—	terminated	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.
Sep 23, 2013	Z-2043-2015	—	terminated	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.
Aug 24, 2012	Z-2345-2012	—	terminated	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.
Nov 3, 2010	Z-0445-2011	—	terminated	Potential for product failure. Packaging/Storage issue results in compromised integrity and potential product failure during use, leading to potential patient injury.
Jun 29, 2010	Z-0168-2011	—	terminated	Software defect results in improper image brightness, which may result in introduction of artifacts, which may cause misclassification of results and affect classification of tissue types. This may result in misdiagnosis and inappropriate treatment.
Jun 11, 2010	Z-0973-2012	—	terminated	Internal review of validation of pcMF Software kit found that instructions directs user to remove the rear panel, causing the potential for electric shock.
Oct 6, 2009	Z-0935-2012	—	terminated	Reports of no signal displayed on the monitor when FloWire Doppler Guide wires were connected to the Combomap.
Apr 2, 2007	Z-1190-2007	—	terminated	During emissions testing, it was discovered that the product exceeds emissions limits for electromagnetic compatibility.