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"
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Due to a potential failed sterilization process.
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.
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.
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.
Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS).
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 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter.
The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.
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.
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.
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 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
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.
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.
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.
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
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.
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.
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.
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
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
Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
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.