Gentuity, Llc: Catheter, Intravascular, Diagnostic
- Recalling firm
- Gentuity, LLC
- Product
- Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
- Reason
- 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 mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-23
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, FL, GA, IL, MA, MN, NJ, NY, OH, PA, TX and the countries of Belgium, Japan.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/8515cdcc-84e6-46fc-b127-8ce5a30c2f26