HeartFlow AnalysisRecalls & reported problems across all models
Heartflow, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 4 models of HeartFlow Analysis by Heartflow, Inc. in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Jan 15, 2021 and Sep 22, 2026 — classified as 6 injuries, 38 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (22 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported HeartFlow Analysis problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings22
- False Negative Result21
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Insufficient Information17
- Angina4
- Chest Pain2
- Dyspnea1
- Myocardial Infarction1
HeartFlow Analysis models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HeartFlow Analysis FFRct version 3System, Image Processing, Radiological35 reports
- Heartflow Analysis 4.xSystem, Image Processing, Radiological5 reports
- HeartFlow Analysis FFRct version 2Coronary Vascular Physiologic Simulation Software3 reports
- HeartFlow Analysis FFRct version 3Coronary Vascular Physiologic Simulation Software1 report
Recent HeartFlow Analysis adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Incorrect, 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 50859947 ↗MalfunctionSep 18, 2026False Negative Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822565 ↗MalfunctionSep 18, 2026Incorrect, 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 50813309 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
Heartflow identified a Heartflow Analysis output was incorrectly released with FFRct values provided for the Right Coronary Artery (RCA) system.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50813306 ↗MalfunctionSep 18, 2026False Negative Result
Heartflow identified a potential false negative result.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50813305 ↗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 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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