HeartFlow Analysis FFRct version 3 (UDI 00853341006053)Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853341006053), received between Dec 20, 2023 and Dec 20, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “False Negative Result” (1 report).
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
- False Negative Result1
Patient problems
- Angina1
- Dyspnea1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 20, 2023False Negative Result; False Negative Result
HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT HAD A CORONARY COMPUTED TOMOGRAPHY ANGIOGRAPHY (CCTA) PERFORMED ON (B)(6) 2022 AND APPROXIMATELY 1 MONTH LATER, HAD A HEARTFLOW FFRCT ANALYSIS PERFORMED ON 27-SEP-2022. THE RADIOLOGIST AT THE TIME DICTATED THE LEFT MAIN CORONARY VESSEL TO BE (B)(4). THE HCP REPORTED THE PATIENT PRESENTED WITH CHEST PAIN AND DYSPNEA OF EXERTION (DOE), ON AN UNKNOWN DATE IN EARLY 2023, WHICH WAS WORSENING STATUS POST (S/P). LEFT HEART CATHETERIZATION (LHC) WAS PERFORMED ON (B)(6) 2023, SHOWING SEVERE MULTIVESSEL CORONARY ARTERY DISEASE (CAD) AND LEFT MAIN DISEASE WITH (B)(4) STENOSIS NOW S/P. THE PATIENT UNDERWENT AN URGENT CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY X4 ( LIMA-LAD, RAD-OM1, V-D2, V-PDA).
Patient problems: Angina; Dyspnea
MAUDE report 18370041 ↗
Other Coronary Vascular Physiologic Simulation Software devices
- FFRct v2.1Heartflow, Inc. · Coronary Vascular Physiologic Simulation Software90 reports
- HeartFlow Analysis FFRct version 2Heartflow, Inc. · Coronary Vascular Physiologic Simulation Software3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.