EndoFLIP EF-325NRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521809420), received between Feb 16, 2023 and May 14, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026

  ENDOFLIP PROBE AND SYRINGE FAILED THE PRE-CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25169066 ↗
• MalfunctionMay 13, 2026Environmental Particulates

  IT WAS REPORTED THAT THE CATHETER HAD BLACK DEBRIS IN THE SYRINGE OUT OF THE BOX. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND BLACK PARTICULATE MATTER SUSPENDED IN THE SALINE SOLUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163818 ↗
• MalfunctionMay 13, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WERE BLACK DEBRIS IN THE SYRINGE. THERE WAS NO PATIENT INVOLVEMENT. FUNCTIONAL TESTING OF THE RETURN DEVICE CONFIRMED A MANUFACTURING FAULT. THE ROOT CAUSE OF THE OBSERVED CONDITION WAS DETERMINED TO BE A RESULT OF A MANUFACTURING ACTIVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163810 ↗
• MalfunctionMay 13, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE CATHETER HAD BLACK DEBRIS IN THE SYRINGE. THERE WAS NO PATIENT INVOLVEMENT. FUNCTIONAL TESTING OF THE RETURN DEVICE CONFIRMED A MANUFACTURING FAULT. THE ROOT CAUSE OF THE OBSERVED CONDITION WAS DETERMINED TO BE A RESULT OF A MANUFACTURING ACTIVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163804 ↗
• MalfunctionApr 13, 2026Device Difficult to Program or Calibrate; Contamination /Decontamination Problem

  EVENT DESCRIPTION IT WAS REPORTED THAT THE CATHETER FAILED THE PRE-USE CHECK AND WAS ATTEMPTED TWICE. ANOTHER CATHETER WAS USED SUCCESSFULLY. THERE WAS NO PATIENT OR USER HARM. THE REPORTED CONDITION WAS NOT CONFIRMED. FUNCTIONAL TESTING OF THE RETURN DEVICE CONFIRMED A UNREPORTED ISSUE. THE ROOT CAUSE OF THE OBSERVED CONDITION WAS DETERMINED TO BE A RESULT OF A MANUFACTURING ACTIVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860005 ↗
• MalfunctionApr 7, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT WHEN FOUR SYRINGES FOR THE CATHETERS WERE LOOKED AT, IT APPEARED AS IT HAD DEBRIS IN THE SYRINGES. THERE WAS NO PATIENT INVOLVEMENT. FUNCTIONAL TESTING OF THE RETURN DEVICE CONFIRMED A MANUFACTURING FAULT. THE ROOT CAUSE OF THE OBSERVED CONDITION WAS DETERMINED TO BE A RESULT OF A MANUFACTURING ACTIVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800838 ↗
• MalfunctionApr 7, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT WHEN FOUR SYRINGES FOR THE CATHETERS WERE LOOKED AT, IT APPEARED AS IT HAD DEBRIS IN THE SYRINGES. THERE WAS NO PATIENT INVOLVEMENT. FUNCTIONAL TESTING OF THE RETURN DEVICE CONFIRMED A MANUFACTURING FAULT. THE ROOT CAUSE OF THE OBSERVED CONDITION WAS DETERMINED TO BE A RESULT OF A MANUFACTURING ACTIVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800815 ↗
• MalfunctionApr 7, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT WHEN FOUR SYRINGES FOR THE CATHETERS WERE LOOKED AT, IT APPEARED AS IT HAD DEBRIS IN THE SYRINGES. THERE WAS NO PATIENT INVOLVEMENT. FUNCTIONAL TESTING OF THE RETURN DEVICE CONFIRMED A MANUFACTURING FAULT. THE ROOT CAUSE OF THE OBSERVED CONDITION WAS DETERMINED TO BE A RESULT OF A MANUFACTURING ACTIVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800803 ↗
• MalfunctionApr 7, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT WHEN FOUR SYRINGES FOR THE CATHETERS WERE LOOKED AT, IT APPEARED AS IT HAD DEBRIS IN THE SYRINGES. THERE WAS NO PATIENT INVOLVEMENT. FUNCTIONAL TESTING OF THE RETURN DEVICE CONFIRMED A MANUFACTURING FAULT. THE ROOT CAUSE OF THE OBSERVED CONDITION WAS DETERMINED TO BE A RESULT OF A MANUFACTURING ACTIVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800784 ↗
• MalfunctionDec 8, 2025Inflation Problem

  BALLOON CATHETER FAILED TO INFLATE- FAILED TEST. NEW CATHETER BROUGHT INTO PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23736198 ↗
• MalfunctionJun 14, 2024Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  ACCORDING TO THE REPORTER, THE CATHETER WAS USED TO TEST THE SYSTEM AFTER THE COMMUNICATION FAILURE. THE CATHETER FAILED TO PRE CHECK ON SENSOR 11. TRIED TO PRE CHECK TWICE AND THE SECOND CATHETER PASSED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537572 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE TIP OF THE CATHETER CAUSED A TEAR IN THE HYPO LARYNX RIGHT ABOVE THE ESOPHAGUS. THIS WAS A 3RD TIME REDO PROCEDURE, SO THE ABDOMINAL/MEDIASTINAL PORTION WAS MORE COMPLEX BUT UNRELATED TO THE INJURY THAT OCCURRED. THE PATIENT DID REQUIRE A PROLONGED HOSPITALIZATION BUT NO ADDITIONAL PROCEDURES (WAS MANAGED NONOPERATIVELY). NOTHING UNUSUAL ABOUT THE CATHETER WAS NOTICED. THE PATIENT IS NOW STABLE AND DOING WELL.

  Patient problems: Laceration(s)

  MAUDE report 19094003 ↗
• MalfunctionSep 13, 2023

  ENDOFLIP WOULD NOT CALIBRATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17735370 ↗
• MalfunctionJun 28, 2023Improper or Incorrect Procedure or Method

  NURSE WAS PRIMING THE ENDOFLIP CATHETER; SHE LEFT THE CAP ON, AND THE CATHETER FAILED TESTING DUE TO THIS ERROR. PATIENT WAS NOT IN THE ROOM YET. A NEW CATHETER WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216011 ↗
• MalfunctionMay 25, 2023Calibration Problem

  PROBE DID NOT CALIBRATE CORRECTLY. FOUND PRIOR TO PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17001775 ↗
• MalfunctionMar 21, 2023Inadequacy of Device Shape and/or Size; Pressure Problem; Inadequacy of Device Shape and/or Size; Pressure Problem

  ACCORDING TO THE REPORTER, THE CATHETER INFLATED TO 50ML, PRESSURE 4.7MMHG AND DEFLATED TO 0ML, PRESSURE -5.5MMHG. ALTHOUGH MMHG POST DEFLATION WAS -5.5MMHG, SURGEON PROCEEDED WITH THE CATHETER. THE SURGEON IMMEDIATELY FELT THE DI WAS OFF. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16585755 ↗
• InjuryFeb 16, 2023Gradient Increase; Inadequacy of Device Shape and/or Size; Gradient Increase; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE REPORTER, THE SURGEON REPORTED JUMPS IN DISTENSIBILITY. PROCEDURE WAS PERFORMED ON AN ACHALASIA PATIENT WITH AN INITIAL DI OF 1.2 WHICH THEN JUMPED TO 5. BASED ON THE DI OF 5, THE SURGEON MADE A CLINICAL ASSESSMENT NOT TO PERFORM A MYOTOMY AND ENDED UP PERFORATING THE PATIENT DURING A SEPARATE FOLLOW-UP PROCEDURE. THE PATIENT WAS STILL IN THE HOSPITAL DUE TO THIS ADVERSE EVENT.

  Patient problems: Perforation of Esophagus

  MAUDE report 16389231 ↗