EndoFLIP EF-100 (UDI 10884521809307)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521809307), received between Jan 23, 2023 and Oct 15, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Smoking” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Thermal Decomposition of Device; Failure to Power Up; Smoking; Thermal Decomposition of Device; Failure to Power Up; Smoking

  IT WAS REPORTED THAT DURING THE PROCEDURE, BETWEEN THE FIRST AND SECOND MEASUREMENT, THE SYSTEM'S MODULE SMOKED, A SMELL OCCURRED AND THEN IT TURNED OFF. IT SEEMED A COMPONENT HAD BLOWN. THE SURGEON PULLED OUT THE CATHETER AND CONTINUED THE SURGERY WITHOUT THE DEVICE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 23277819 ↗
• MalfunctionApr 25, 2024Intermittent Continuity; Smoking; Intermittent Continuity; Smoking

  ACCORDING TO THE REPORTER, THE UNIT BEEPS WHEN POWERED ON. THE FAN COMES ON AND IT CONTINUED TO BEEP. CUSTOMER TRIED DIFFERENT POWER PACKS AND RESTARTED AND THE UNIT JUST DID NOT WORK. THERE WAS A SMOKE SEEN COMING FROM THE UNIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182714 ↗
• MalfunctionJan 23, 2023Smoking; Adverse Event Without Identified Device or Use Problem; Unintended Electrical Shock; Smoking; Adverse Event Without Identified Device or Use Problem; Unintended Electrical Shock

  ACCORDING TO THE REPORTER, THE UNIT WAS FLIPPED ON AND THE UNIT ITSELF SPARKED AND STARTED SMOKING FROM UNDER THE MACHINE BELOW THE ON/OFF TOGGLE. THE CUSTOMER WAS SHOCKED BY THE DEVICE. THE DEVICE WAS NOT SERVICED OR OPENED PRIOR TO THE INCIDENT. THE SHOCK WAS FROM THE MACHINE, THE POWER BRICK WAS NOT INVOLVED.

  Patient problems: Electric Shock

  MAUDE report 16225545 ↗