RegWardenFDA facility compliance records
Facility

GENTUITY, LLC

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2026: 1 recalls20172018201920202021202220232024202512026
  • Recalls (1)

Devices registered here (2)

  • Optical Coherence Tomography, Intravascular Catheter
    Product code ORD (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1200
  • System, Imaging, Optical Coherence Tomography (Oct)
    Product code NQQ (opens in a new tab) · Class II · Radiology · 21 CFR 892.1560

Recalls & enforcement

  • Class IIOngoing2026-03-23
    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. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and miti…

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “GENTUITY, LLC (FEI 3021630097) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3021630097-gentuity-llc/

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