FFRct v2.1Recalls & reported problems
Heartflow, Inc. · HeartFlow FFRct is an image analysis software developed for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography 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 of coronary artery disease. HeartFlow FFRct is independent of imaging equipment, imaging protocols and equipment vendors. HeartFlow analyses are performed on previously physician-acquired image data and are unrelated to acquisition equipment and workstations. · Class 2
Quick summary
This HeartFlow FFRct software analyzes CT heart scans to estimate blood flow through the coronary arteries. Of its 90 reports, 3 describe injuries and no deaths are recorded. Reports describe the manufacturer identifying potential false negative results, meaning the software may have missed a significant narrowing in a coronary artery. Most reports contain no information about the patient. No recalls name this device.
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
- 90
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 00853341006015), received between May 24, 2017 and Apr 17, 2020 — classified as 3 injuries, 87 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (90 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 Result90
Patient problems
- No Information67
- No Consequences Or Impact To Patient43
- Myocardial Infarction2
- Chest Pain1
Recent adverse event reports
The 25 most recent of 90 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2020False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Information
MAUDE report 9975523 ↗MalfunctionMar 25, 2020False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9879536 ↗MalfunctionJan 27, 2020False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 9634655 ↗MalfunctionJan 27, 2020False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9633876 ↗MalfunctionJan 22, 2020False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 9616474 ↗MalfunctionJan 22, 2020False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 9616181 ↗MalfunctionJan 21, 2020False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Information
MAUDE report 9613397 ↗MalfunctionJan 21, 2020False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9613059 ↗MalfunctionJan 17, 2020False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Information
MAUDE report 9601815 ↗MalfunctionDec 23, 2019False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Information
MAUDE report 9512348 ↗MalfunctionDec 20, 2019False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Information
MAUDE report 9503746 ↗MalfunctionDec 19, 2019False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9497804 ↗MalfunctionDec 19, 2019False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9492862 ↗MalfunctionDec 19, 2019False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Information
MAUDE report 9492707 ↗MalfunctionDec 17, 2019False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Information
MAUDE report 9477842 ↗MalfunctionDec 14, 2019False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Information
MAUDE report 9470548 ↗MalfunctionDec 10, 2019False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Information
MAUDE report 9447606 ↗MalfunctionDec 4, 2019False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Information
MAUDE report 9413442 ↗MalfunctionDec 3, 2019False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Information
MAUDE report 9406957 ↗MalfunctionDec 3, 2019False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Information
MAUDE report 9406083 ↗MalfunctionNov 26, 2019False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 9379358 ↗MalfunctionNov 22, 2019False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Information
MAUDE report 9365309 ↗MalfunctionNov 21, 2019False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Information
MAUDE report 9359375 ↗MalfunctionNov 21, 2019False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Information
MAUDE report 9356858 ↗MalfunctionNov 21, 2019False Negative Result; False Negative Result
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Patient problems: No Information
MAUDE report 9354852 ↗
Other Coronary Vascular Physiologic Simulation Software devices
- HeartFlow Analysis FFRct version 2Heartflow, Inc. · Coronary Vascular Physiologic Simulation Software3 reports
- HeartFlow Analysis FFRct version 3Heartflow, Inc. · Coronary Vascular Physiologic Simulation Software1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.