HeartFlow Analysis FFRct version 3 (UDI 00853341006060)Recalls & reported problems
Heartflow, Inc. · The HeartFlow Analysis is AI-based medical device 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 in the risk stratification and evaluation of coronary artery disease. The software displays coronary anatomy and functional information using graphics and text, including computed and derived quantities of percent stenosis, plaque volumes, 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
Quick summary
This HeartFlow Analysis software reads CT scans of the heart to help doctors assess coronary artery disease. Most of the 35 reports describe analysis results that were wrong or incomplete, such as blocked areas being missed or readings released for the wrong artery. Three reports involve injuries and there are no deaths. There are no recalls name this device. Reports have dropped sharply in the past 12 months, from 16 to none.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00853341006060), received between Mar 24, 2023 and Sep 11, 2025 — classified as 3 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (19 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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings19
- False Negative Result15
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Insufficient Information16
- Chest Pain2
- Angina1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
HEARTFLOW IDENTIFIED A HEARTFLOW ANALYSIS WAS INCORRECTLY RELEASED WITH FFRCT VALUES PROVIDED FOR THE LEFT ANTERIOR DESCENDING (LAD) SYSTEM WITH A STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23031417 ↗MalfunctionSep 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
HEARTFLOW IDENTIFIED A COMPUTED TOMOGRAPHY (CT) DATASET WAS POTENTIALLY INCORRECTLY ACCEPTED FOR PROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22938920 ↗MalfunctionAug 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
HEARTFLOW IDENTIFIED A COMPUTED TOMOGRAPHY (CT) DATASET WAS POTENTIALLY INCORRECTLY ACCEPTED FOR PROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22928373 ↗MalfunctionAug 27, 2025False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22909424 ↗MalfunctionAug 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
HEARTFLOW IDENTIFIED A POTENTIAL OCCLUSION WAS MISSED IN THE LCX ON THE HEARTFLOW ANALYSIS THAT WAS RELEASED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22743246 ↗MalfunctionAug 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
HEARTFLOW IDENTIFIED A POTENTIAL COMPUTED TOMOGRAPHY (CT) DATASET WAS INCORRECTLY ACCEPTED FOR PROCESSING AN ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22743239 ↗MalfunctionJun 13, 2025False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22206338 ↗MalfunctionMay 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
HEARTFLOW IDENTIFIED A HEARTFLOW ANALYSIS WAS INCORRECTLY RELEASED WITH FFRCT VALUES PROVIDED FOR THE RIGHT CORONARY ARTERY (RCA) SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22056775 ↗MalfunctionMay 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
HEARTFLOW IDENTIFIED A HEARTFLOW ANALYSIS WAS INCORRECTLY RELEASED WITH FFRCT VALUES PROVIDED FOR THE RIGHT CORONARY ARTERY (RCA) SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22055964 ↗MalfunctionMay 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
HEARTFLOW IDENTIFIED THAT A COMPUTED TOMOGRAPHY (CT) DATASET WAS POTENTIALLY INCORRECTLY ACCEPTED FOR PROCESSING AN ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21973201 ↗MalfunctionApr 24, 2025False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: Insufficient Information
MAUDE report 21903027 ↗MalfunctionApr 24, 2025False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: Insufficient Information
MAUDE report 21902732 ↗MalfunctionApr 17, 2025False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21859483 ↗MalfunctionJan 10, 2025False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21130101 ↗MalfunctionDec 10, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
HEARTFLOW IDENTIFIED A POTENTIAL COMPUTED TOMOGRAPHY (CT) DATASET WAS INCORRECTLY ACCEPTED FOR PROCESSING AN ANALYSIS. A HEALTHCARE PROFESSIONAL (HCP) ADDITIONALLY REPORTED "THIS IS A CASE OF CHRONIC CORONARY SYNDROME WITHOUT SYMPTOMS. IN (B)(6) 2023 THE PATIENT ALSO UNDERWENT A STRESS ECG TEST WITH NEGATIVE RESULTS. THEREFORE, NO FURTHER SCANS ARE BEING CONSIDERED." THE HCP NOTED THAT THE PATIENT SEEMS TO PROPERLY FOLLOW THE INDICATIONS FOR WHEN TO TAKE THEIR MEDICATIONS. THE PATIENT IS SCHEDULED FOR CONSULTATION EVERY 6 MONTHS AND HAD A RECENT VISIT ON (B)(6) 2024. THEIR NEXT VISIT WILL BE IN (B)(6) OF 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20898383 ↗MalfunctionDec 5, 2024False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: Insufficient Information
MAUDE report 20859559 ↗MalfunctionOct 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
HEARTFLOW IDENTIFIED A POTENTIAL COMPUTED TOMOGRAPHY (CT) DATASET WAS INCORRECTLY ACCEPTED FOR PROCESSING AN ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 20487141 ↗MalfunctionSep 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
HEARTFLOW IDENTIFIED A POTENTIAL COMPUTED TOMOGRAPHY (CT) DATASET WAS INCORRECTLY ACCEPTED FOR PROCESSING AN ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 20273801 ↗MalfunctionSep 17, 2024False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED POTENTIAL OVERSIZED MODELING OF THE LEFT MAIN ARTERY IN THE HEARTFLOW ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 20242151 ↗MalfunctionSep 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
HEARTFLOW IDENTIFIED A POTENTIAL INCORRECTLY PROVIDED ANALYSIS FOR THE LAD VESSEL AND RCA VESSEL MODELED TOO LARGE IN THE HEARTFLOW ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 20131629 ↗MalfunctionSep 3, 2024False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED POTENTIAL OVERSIZED MODELING OF THE LEFT MAIN ARTERY IN THE HEARTFLOW ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 20131357 ↗MalfunctionAug 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
HEARTFLOW IDENTIFIED A POTENTIAL COMPUTED TOMOGRAPHY (CT) DATASET WAS INCORRECTLY ACCEPTED FOR PROCESSING AN ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20043701 ↗MalfunctionJul 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
HEARTFLOW IDENTIFIED A HEARTFLOW ANALYSIS WAS INCORRECTLY RELEASED WITH FFRCT VALUES PROVIDED FOR THE RIGHT CORONARY ARTERY (RCA) SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19672341 ↗MalfunctionJun 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
HEARTFLOW IDENTIFIED A POTENTIAL COMPUTED TOMOGRAPHY (CT) DATASET WAS INCORRECTLY ACCEPTED FOR PROCESSING AN ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19541004 ↗MalfunctionMay 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
HEARTFLOW IDENTIFIED A POTENTIAL COMPUTED TOMOGRAPHY (CT) DATASET WAS INCORRECTLY ACCEPTED FOR PROCESSING AN ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 19337706 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.