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HeartFlow Analysis FFRct version 2Recalls & reported problems

Heartflow, Inc. · The HeartFlow Analysis is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with functional information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease. The HeartFlow Analysis is performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations. · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00853341006039), received between Jan 15, 2021 and Sep 1, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “False Negative Result” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • False Negative Result3

Patient problems

  • Angina2
  • Insufficient Information1
  • Myocardial Infarction1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjurySep 1, 2022False Negative Result; False Negative Result

    DURING REVIEW OF CLINICAL STUDY DATA, IT WAS IDENTIFIED THAT A PATIENT ENROLLED IN THE STUDY (B)(6) 2020, HAD RECEIVED A HEARTFLOW ANALYSIS WHERE THE PATIENT HAD A POSITIVE LAD AND AN RCA WITH A BORDERLINE DISTAL VALUE. THE PATIENT WAS SCHEDULED FOR A CORONARY ANGIOGRAM (CAG) DUE TO THE LAD RESULT. THE STUDY INVESTIGATORS REPORTED A POTENTIAL FALSE NEGATIVE IN THE RCA AS BEFORE THE SCHEDULED CAG, ON (B)(6) 2020, THE PATIENT WAS URGENTLY ADMITTED IN ANOTHER HOSPITAL DUE TO UNSTABLE ANGINA WHERE PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED AND THE RCA 4PD BRANCH WAS TREATED WITH A DRUG-COATED BALLOON (DCB).

    Patient problems: Angina

    MAUDE report 15341822 ↗
  • InjuryApr 23, 2021False Negative Result; False Negative Result

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT AND THE PATIENT HAD AN ACUTE EVENT WITH LAD AND DIAGONAL INFARCTS. THE COMPANY REPRESENTATIVE FOLLOWED UP WITH THE CUSTOMER FOR ADDITIONAL INFORMATION CONFIRMING THE PATIENT PRESENTED WITH CHEST PAIN, AND HAD AN ECHO AND TROPONIN TESTS PERFORMED. THE PATIENT HAD 'WALL MOTION ABNORMALITY' ON ECHO AND ELEVATED TROPONINS. THE PATIENT HAD AN EMERGENCY PERCUTANEOUS CORONARY INTERVENTION (PCI) INCLUDING AN INVASIVE CORONARY ANGIOGRAPHY (ICA).

    Patient problems: Angina; Myocardial Infarction

    MAUDE report 11719122 ↗
  • MalfunctionJan 15, 2021False Negative Result

    HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.

    Patient problems: Insufficient Information

    MAUDE report 11181805 ↗

Other Coronary Vascular Physiologic Simulation Software devices

All Coronary Vascular Physiologic Simulation Software devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.