Recall database

Gentuity, LLC recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–1 of 1 recalls

Class IIOngoingZ-1823-2026

Gentuity, LLC recalls Gentuity HF-OCT Imaging System Model G10-01

The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters.…

Diagnostic Intravascular Catheter
Device Design

Gentuity, LLCMAApr 22, 2026