Volcano Recalls
15 recalls on record in the United States
Volcano Corporation recalls Volcano Imaging System s5i REF 807400001; CORE Mobile Imagin
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.
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Volcano Corporation recalls Refinity Short Tip Rotational Intravascular Ultrasound (IVUS
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.
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Volcano Corporation recalls Refinity Rotational Intravascular Ultrasound (IVUS) Catheter
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.
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Volcano Corp recalls Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), R
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"
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Volcano Corp recalls Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN:
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
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Volcano Corp recalls Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN:
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
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Volcano Corp recalls Philips OmniWire Pressure guide wire REF 89185J PN 300000252
Due to a potential failed sterilization process.
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Volcano Corp recalls IntraSight Mobile IVUS Systems, Model: 797415, Part numbers:
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.
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Volcano Corp recalls MM-TSM (Touch Screen Module/Secondary Controller/Bedside Con
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.
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Volcano Corporation recalls SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, wi
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.
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Volcano Corporation recalls Philips Volcano FFR software used in the following systems c
Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS).
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Volcano Corporation recalls Visions PV .035 Digital IVUS Catheter, Catalog Number/Part N
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.
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Volcano Corporation recalls Visions PV .035 Digital IVUS Catheter, Catalog Number/Part N
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.
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Volcano Corporation recalls Philips Volcano CORE M2 Vascular System, Part # 400-0100.17,
The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.
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Volcano Corp recalls Philips IntraSight Plus REF: 797423 and 797417 100-120v-22
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
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