Volcano Corporation
Medical device manufacturer in San Diego, CA.
55510(k) clearances
0PMA approvals
36recalls
Device types
- IYO System, Imaging, Pulsed Echo, Ultrasonic 19
- OBJ Catheter, Ultrasound, Intravascular 14
- DQX Wire, Guide, Catheter 7
- OWB Interventional Fluoroscopic X-Ray System 5
- DQY Catheter, Percutaneous 3
- KKX Drape, Surgical, Antimicrobial 1
- DXO Transducer, Pressure, Catheter Tip 1
- QEZ Aspiration Thrombectomy Catheter 1
- MMX Device, Percutaneous Retrieval 1
- DTK Filter, Intravascular, Cardiovascular 1
- DSK Computer, Blood-Pressure 1
- DSA Cable, Transducer And Electrode, Patient… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K210235 | Verrata PLUS Pressure Guide WireDQX · Special | 04/15/2021SE |
| K203719 | IntraSight MobileIYO · Special | 01/19/2021SE |
| K202543 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm…DQX · Special | 09/28/2020SE |
| K192886 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm…DQX · Traditional | 03/26/2020SE |
| K190626 | SyncVision SystemOWB · Traditional | 04/12/2019SE |
| K190078 | IntraSightDSA · Special | 02/11/2019SE |
| K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound…IYO · Traditional | 04/11/2018SE |
| K172455 | CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2…IYO · Special | 10/25/2017SE |
| K172574 | SyncVision SystemOWB · Traditional | 10/05/2017SE |
| K170385 | CORE M2 Vascular SystemIYO · Special | 04/06/2017SE |
| K160583 | REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipOBJ · Traditional | 10/26/2016SE |
| K161887 | Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire…DQX · Special | 09/20/2016SE |
| K161756 | SyncVision SystemOWB · Traditional | 09/05/2016SE |
| K153094 | Visions PV .035 Digital IVUS CatheterOBJ · Special | 12/31/2015SE |
| K153369 | SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5izIYO · Special | 12/22/2015SE |
| K152582 | CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter BoxDSK · Special | 12/03/2015SE |
| K152829 | Visions PV.014P RX Digital IVUS CatheterOBJ · Special | 11/19/2015SE |
| K150442 | Volcano Visions PV .018 Digital IVUS CatheterOBJ · Traditional | 09/04/2015SE |
| K143701 | Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV .014…OBJ · Traditional | 08/26/2015SE |
| K151904 | SyncVision SystemOWB · Special | 07/31/2015SE |
| K150262 | Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugularDTK · Traditional | 04/03/2015SE |
| K150441 | Volcano iFR Modality, iFR Scout featureIYO · Special | 03/20/2015SE |
| K143122 | Volcano iFR Harvest Software (Offline)IYO · Special | 02/20/2015SE |
| K133323 | Volcano Ifr ModalityIYO · Traditional | 03/14/2014SE |
| K140291 | Volcano Core Control Pad, Accessory to the Volcano S5/S5I Intravascular Ultrasound…IYO · Special | 03/07/2014SE |
| K133681 | Crux Snare Filter Retrieval SetMMX · Traditional | 01/30/2014SE |
| K133641 | Core Control Pad, Core Series SW V3.4 Installation Kit, Core, Core MobileIYO · Special | 12/20/2013SE |
| K132558 | Sync-Rx SystemOWB · Traditional | 12/12/2013SE |
| K133142 | Volcano Lomap,Volcano Lomap Option Kit for Mobile System,Volcano Lomap Option for…IYO · Special | 11/15/2013SE |
| K132659 | Volcano Preview Forward-Looking Ivus SystemDQY · Special | 09/27/2013SE |
| K131288 | Verrata Pressure Guide WireDQX · Special | 06/21/2013SE |
| K123482 | Reflow Aspiration CatheterQEZ · Traditional | 04/29/2013SE |
| K122826 | Preview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter Model 87000…DQY · Traditional | 04/24/2013SE |
| K123898 | Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemIYO · Special | 01/14/2013SE |
| K121273 | Visions PV .035 Ditital Ivus CatheterOBJ · Abbreviated | 09/10/2012SE |
| K120697 | Eagle Eye Platinum ST CatheterOBJ · Special | 04/05/2012SE |
| K113486 | Volcano S5I Intravascular Ultracound Imaging and Pressure SystemIYO · Special | 01/27/2012SE |
| K112035 | Valet Micro CatheterDQY · Traditional | 01/05/2012SE |
| K111395 | Primewire Prestige PlusDQX · Special | 08/01/2011SE |
| K111706 | Volcano S5IINTRAVASCULAR Imaging and Pressure SystemIYO · Special | 07/15/2011SE |
| K100930 | Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300, 8300JDQX · Special | 04/30/2010SE |
| K092596 | Eagle Eye Platinum Digital Ivus CatheterOBJ · Abbreviated | 12/10/2009SE |
| K082229 | S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow SystemIYO · Special | 10/08/2008SE |
| K080891 | Revolution 45MHZ Ivus Imaging CatheterOBJ · Special | 05/12/2008SE |
| K073473 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus Imaging Catheter…OBJ · Special | 01/14/2008SE |
| K071554 | Volcano S5/S5I Intravascular Imaging and Pressure SystemOBJ · Special | 01/04/2008SE |
| K071660 | Visions PV 8.2 Intravascular Ultrasound Imaging Catheter, Model 88900OBJ · Special | 08/31/2007SE |
| K070487 | Smartwire Pressure Guide Wire, Model 66XXDXO · Special | 03/16/2007SE |
| K061215 | Volcano S51 Family of Imaging SystemsIYO · Special | 08/10/2006SE |
| K060483 | Volcano Angio-Ivus Mapping (Aim) SystemIYO · Traditional | 06/23/2006SE |
| K052348 | In Vision Gold with Spin Vision, Model 891 SVIYO · Traditional | 12/02/2005SE |
| K052395 | Sterile Equipment CoversKKX · Traditional | 12/01/2005SE |
| K051920 | Volcano S5 Imaging System, Model 804200-001IYO · Special | 08/19/2005SE |
| K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano Vh-Ivus System, Model…OBJ · Special | 08/18/2005SE |
| K050995 | Revolution 45 MHZ Rotational Ivus Imaging CatheterOBJ · Special | 06/20/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2221-2025 Class II | Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF:…Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter… | 06/13/2025Open, Classified |
| Z-1270-2022 Class II | Philips OmniWire Pressure guide wire REF 89185J PN 300000252891Due to a potential failed sterilization process. | 05/16/2022Terminated |
| Z-1302-2022 Class III | Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only…Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications | 05/13/2022Open, Classified |
| Z-1301-2022 Class III | Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only…Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications | 05/13/2022Open, Classified |
| Z-0917-2022 Class III | MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers:…Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become… | 02/03/2022Open, Classified |
| Z-0901-2022 Class III | IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of… | 01/24/2022Open, Classified |
| Z-0885-2022 Class II | SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.xIf FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session… | 01/19/2022Open, Classified |
| Z-0674-2020 Class II | Philips Volcano FFR software used in the following systems connected to the McKesson…Interoperability issue that affects certain systems that use the recalled software when it is connected to… | 11/07/2018Terminated |
| Z-0727-2019 Class II | Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272…Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the… | 10/17/2018Terminated |
| Z-0726-2019 Class II | Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173…Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the… | 10/17/2018Terminated |
| Z-1891-2018 Class II | Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the…The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in… | 03/22/2018Terminated |
| Z-0189-2018 Class II | Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF…On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during use, and the… | 11/03/2017Terminated |
| Z-1776-2017 Class II | Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number:…High complaint rates of kinking near the junction of the proximal shaft to telescope section of the… | 03/29/2017Terminated |
| Z-1775-2017 Class II | Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number:…High complaint rates of kinking near the junction of the proximal shaft to telescope section of the… | 03/29/2017Terminated |
| Z-1813-2016 Class II | Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4…Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In… | 04/25/2016Terminated |
| Z-1042-2016 Class II | Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile…Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may… | 02/05/2016Terminated |
| Z-1041-2016 Class II | Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment…Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may… | 02/05/2016Terminated |
| Z-2718-2015 Class II | Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing…Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter… | 07/22/2015Terminated |
| Z-2136-2015 Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with…A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain… | 06/22/2015Terminated |
| Z-2135-2015 Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with…A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain… | 06/22/2015Terminated |
| Z-2134-2015 Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with…A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain… | 06/22/2015Terminated |
| Z-2133-2015 Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with…A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain… | 06/22/2015Terminated |
| Z-2132-2015 Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with…A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain… | 06/22/2015Terminated |
| Z-2131-2015 Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4…A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain… | 06/22/2015Terminated |
| Z-1845-2015 Class II | Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is…During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in… | 06/04/2015Terminated |
| Z-1844-2015 Class II | Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is…During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in… | 06/04/2015Terminated |
| Z-2636-2014 Class II | Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use.…Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of… | 08/13/2014Terminated |
| Z-2045-2015 Class II | ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map -…A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's… | 09/23/2013Terminated |
| Z-2044-2015 Class II | Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System…A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's… | 09/23/2013Terminated |
| Z-2043-2015 Class II | Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System…A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's… | 09/23/2013Terminated |
| Z-2345-2012 Class II | Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or…The display on the system has the potential to change. In house testing eventually identified the unique… | 08/24/2012Terminated |
| Z-0445-2011 | Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting…Potential for product failure. Packaging/Storage issue results in compromised integrity and potential… | 11/03/2010Terminated |
| Z-0168-2011 | Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to…Software defect results in improper image brightness, which may result in introduction of artifacts, which… | 06/29/2010Terminated |
| Z-0973-2012 | Volcano pcFM Software Kit ; Manufactured by: Volcano Corporation, 2870 Kilgore Road…Internal review of validation of pcMF Software kit found that instructions directs user to remove the rear… | 06/11/2010Terminated |
| Z-0935-2012 | FloWire Doppler Guide wires. Volcano Corporation, Rancho Cardova, Ca. The Volcano…Reports of no signal displayed on the monitor when FloWire Doppler Guide wires were connected to the Combomap. | 10/06/2009Terminated |
| Z-1190-2007 | Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of…During emissions testing, it was discovered that the product exceeds emissions limits for electromagnetic… | 04/02/2007Terminated |