FFR Link H749555100R0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729939603), received between Apr 9, 2025 and May 7, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Data Problem

  IT WAS REPORTED THAT INACCURATE VALUES OCCURRED. A FFR LINK WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE WAVE LENGTHS ARE SHOWING TO DIFFERENT WAVEFORMS. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115675 ↗
• MalfunctionApr 9, 2025Device Displays Incorrect Message; Connection Problem; Device Displays Incorrect Message; Connection Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN FFR LINK WAS SELECTED FOR EXAMINATION OF THE TARGET LESION. DURING USE, THE DEVICE EXPERIENCED AN ERROR AND WAS UNABLE TO SEND WAVEFORMS. BECAUSE OF THIS, THE PROCEDURE WAS NOT ABLE TO BE COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21808571 ↗