Infraredx, Inc.: Medical Device Recalls in 2017

Updated on March 25, 2026.

According to to data from the FDA, there was 1 medical device recall made by Infraredx, Inc. in 2017. See the detail of the recall below.

You can see similar recalls for other firms.

Data Source: FDA.

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TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography The TVC Imaging System is an intravascular imaging device that simultaneously assesses vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid core-containing plaques of interest (LCP) displayed in a map called a Chemogram, and simultaneously generates high resolution IVUS images that display structural details of the vessel and plaque in transverse and longitudinal views