Heartflow Analysis 4.xRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00853341006701), received between Sep 18, 2026 and Sep 22, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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

Recent adverse event reports

The 5 most recent of 5 reports, 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 ↗