Volcano Corp - ComboMap Intravascular Flow and Pressure System - Class 2 Recall

ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-001. Product Usage: The Volcano s5/s5i Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion. VH IVUS intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations. The ComboMap is intended to be used in peripheral and coronary arteries to measure intravascular blood pressure and/or blood flow velocities during diagnostic angiography and/or interventional procedures.
Source: Medical Device Recalls - Category: Medical Equipment Source Type: alerts