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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 2 of 2

Device	Model / Reference	Registries	Class	Status
Pioneer Plus Catheter	PPLUS120	EUDAMEDFDA UDI	Class IIa	Active
CORE M2 Vascular System	400-0100.17	EUDAMEDFDA UDI	Class IIa	Active
FloWire Doppler Guide Wire	1400	EUDAMEDFDA UDI	Class III	Active
s5i	807400001	EUDAMEDFDA UDI	Class IIa	Active
R-100	804547001	EUDAMEDFDA UDI	Class I	Active
CORE Mobile System Medical Equipment	400-0100.07	EUDAMEDFDA UDI	Class IIa	Active
Eagle Eye Platinum RX Digital IVUS Catheter	85900P	EUDAMEDFDA UDI	Class III	Active
IntraSight	797403	EUDAMEDFDA UDI	Class IIa	Active
FloWire Doppler Guide Wire	1403	EUDAMEDFDA UDI	Class III	Active
ComboWire Pressure/Flow Guide Wire	9515	EUDAMEDFDA UDI	Class III	Active
SyncVision Medical Image Processing System	400-0100.10	EUDAMEDFDA UDI	Class IIa	Active
Verrata Plus Pressure Guide Wire	10300JP	EUDAMEDFDA UDI	Class III	Active
Eagle Eye Platinum ST RX Digital IVUS Catheter	85900PST	EUDAMEDFDA UDI	Class III	Active
Refinity ST Rotational IVUS Catheter	89900	EUDAMEDFDA UDI	Class III	Active
CORE Series Precision Guided Therapy System	400-0100.02	EUDAMEDFDA UDI	Class IIa	Active
Visions PV .035 Digital IVUS Catheter	88901	EUDAMEDFDA UDI	Class III	Active
FloWire Doppler Guide Wire	1400J	EUDAMEDFDA UDI	Class III	Active
ComboWire Pressure/Flow Guide Wire	9500	EUDAMEDFDA UDI	Class III	Active
R-100 Sterile Equipment Cover	PBKBG	EUDAMED	Class I	Active
Revolution 45MHz Rotational Imaging Catheter	89000	EUDAMEDFDA UDI	Class III	Active
IntraSight Mobile System	797415	EUDAMEDFDA UDI	Class IIa	Active
R-100 Sterile Equipment Cover	PBKBG	EUDAMEDFDA UDI	Class I	Active
OmniWire Pressure Guide Wire	89185J	EUDAMEDFDA UDI	Class III	Active
Verrata Pressure Guide Wire	10300J	EUDAMEDFDA UDI	Class III	Active
Verrata Plus Pressure Guide Wire	10185P	EUDAMEDFDA UDI	Class III	Active
Verrata Plus Pressure Guide Wire	10300P	EUDAMEDFDA UDI	Class III	Active
OmniWire Pressure Guide Wire	89185	EUDAMEDFDA UDI	Class III	Active
Digital IVUS Sterile Equipment Cover	5902VC	EUDAMED	Class I	Active
Verrata Pressure Guide Wire	10300	EUDAMEDFDA UDI	Class III	Active
Verrata Plus Pressure Guide Wire	10185JP	EUDAMEDFDA UDI	Class III	Active
Visions PV .018 Digital IVUS Catheter	86700	EUDAMEDFDA UDI	Class IIa	Active
SpinVision Sterile Equipment Cover	891BG	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

Volcano Europe BE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.