FFR Link H7495551000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729890010), received between May 6, 2024 and Jun 25, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A FFR LINK AND GE PD OUT CABLE WERE SELECTED FOR USE. DURING CAPITAL EQUIPMENT MAINTENANCE, NO SIGNAL DISPLAYED. THE PD OUT CONNECTION PORT SEEMS TO BE DAMAGED ON THE FFR LINK. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25631412 ↗
• MalfunctionMar 4, 2026Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A FFR LINK WAS SELECTED FOR USE. IT WAS REPORTED THAT THE POLE WAS DAMAGED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512512 ↗
• MalfunctionJun 11, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE FFR LINK WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE. HOWEVER, DURING PREPARATION, THE DEVICE WOULD NOT START, AND THE POWER LED WAS RED AND BLINKING. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183059 ↗
• MalfunctionMar 14, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN FFR LINK WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE FFR LINK WOULD NOT GET A WAVEFORM. THE CASE WAS CANCELED AND THEY HAD THE PATIENT COME BACK THE NEXT DAY. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606592 ↗
• MalfunctionNov 26, 2024Nonstandard Device; Defective Device; Nonstandard Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE FFR LINK WAS SELECTED FOR TREATMENT. HOWEVER, THE POWER CODE WAS FOUND BROKEN AND THE DEVICE COULD NOT BE TURNED ON. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS IN GOOD CONDITION. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS NOT CANCELLED. IT WAS COMPLETED WITH OTHER EQUIPMENT AND THE PATIENT WAS UNDER LOCAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20780329 ↗
• MalfunctionMay 6, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE PROCEDURE WAS NOT COMPLETED. AN FFR LINK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS ABLE TO BE ZEROED SUCCESSFULLY BUT WAS UNABLE TO RECORD. AN "UNEXPECTED BEAT" ERROR WAS RECURRING. REBOOTING THE SYSTEM AND REPLACING THE COMET PRESSURE WIRE DID NOT RESOLVE THE ISSUE AND THE CASE WAS ABANDONED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249965 ↗