HEARTFLOW ANALYSIS
Received Jan 17, 2026 · Event occurred Dec 2, 2025
Report 3021637148-2026-00001 · MDR key 24105440
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
HEARTFLOW IDENTIFIED A HEARTFLOW ANALYSIS WAS INCORRECTLY RELEASED WITH FFRCT VALUES PROVIDED FOR THE RIGHT CORONARY ARTERY (RCA) SYSTEM.
Additional Manufacturer Narrative
AS PART OF HEARTFLOW'S INTERNAL REVIEW, A HEARTFLOW ANALYSIS WAS IDENTIFIED TO HAVE BEEN INCORRECTLY RELEASED WITH FFRCT VALUES PROVIDED FOR THE RIGHT CORONARY ARTERY (RCA). THE INVESTIGATION DETERMINED FFRCT VALUES WERE INCORRECTLY PROVIDED IN THE RCA VESSEL DUE TO MISINTERPRETATION OF THE CT DATA BY THE AUTOMATED TECHNOLOGY AND INSPECTION PROCESS. THE PHYSICIAN WAS NOTIFIED OF THE INVESTIGATION RESULTS AND HAS NOT INDICATED A SAFETY EVENT WITH THE PATIENT AT THIS TIME. THE PHYSICIAN STATED THERE WAS NO DIRECT IMPACT TO PATIENT CARE. HEARTFLOW ANALYSIS INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING WARNINGS: DUE TO THE VARIABILITY IN THE HEARTFLOW ANALYSIS, THE OUTPUT SHOULD BE REVIEWED AS ONE OF SEVERAL CLINICAL DATA POINTS TO BE USED IN CONJUNCTION WITH THE PATIENT'S ORIGINAL CT IMAGES, CLINICAL HISTORY, SYMPTOMS, AND OTHER DIAGNOSTIC TESTS, AS WELL AS AN APPROPRIATELY TRAINED CLINICIAN'S CLINICAL JUDGMENT, TO EVALUATE THE PATIENT. THE HEARTFLOW ANALYSIS PROCESS IS DEPENDENT ON THE QUALITY OF THE IMAGING DATA PROVIDED. THE FFRCT VALUES MAY BE AFFECTED BY ASSUMPTIONS NEEDED TO RESOLVE ANATOMY IN AREAS OF UNCERTAINTY, WHETHER PROVIDED BY THE PHYSICIAN OR MADE BY HEARTFLOW CASE ANALYSTS.