EndoFLIPRecalls & reported problems across all models

We found 8 models of EndoFLIP by Covidien LP in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Apr 4, 2019 and May 14, 2026 — classified as 3 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (7 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

EndoFLIP recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 13, 2026Open, Classified

   Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the product unavailable for clinical procedures.

   Z-2950-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

Most reported EndoFLIP problems

EndoFLIP models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EndoFLIP EF-100

  System, Gastrointestinal Motility (Electrical)
  1 recall0 reports
• Endoflip RFG-EF100

  SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
  1 recall0 reports
• EndoFLIP EF-325N

  SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
  17 reports
• EndoFLIP EF-322N

  SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
  15 reports
• EndoFLIP EF-322N

  System, Gastrointestinal Motility (Electrical)
  3 reports
• EndoFLIP EF-100

  SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
  3 reports
• EndoFLIP DD-961

  SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
  1 report
• Endoflip EF-302

  SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
  1 report

Recent EndoFLIP adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• MalfunctionJun 9, 2025Inflation Problem

  THE DEVICE WILL TYPICALLY INFLATE A BALLOON CATHETER AND GIVE FEEDBACK ON THE PATIENTS MOTILITY. THIS PARTICULAR BALLOON CATHETER FAILED TO INFLATE WITH MULTIPLE ATTEMPTS. THIS EQUIPMENT DID NOT FUNCTIONING PROPERLY AND INCREASED THE TIME OF THE PROCEDURE AND THE AMOUNT OF TIMES THAT THE ESOPHAGUS WAS PASSED THROUGH WITH DEVICES. INCREASING THE RISK OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166480 ↗
• MalfunctionMay 28, 2025Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE THREE CATHETERS FAILED PRE CHECK AND ONE BALLOON LEAKED. REPEATED EACH CATHETERS PRECHECK THREE TIMES. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097240 ↗
• MalfunctionMar 21, 2025

  THE PRE-CHECK OF SETUP THE PISTON SYRINGE STARTED TO FILL WITH AIR FROM THE LARGE BLACK SEAL. THE SYRINGE WAS REMOVED, AND THE AIR WAS REMOVED. THE DEVICE WAS SET UP USING THE SAME EQUIPMENT, AND THE PRE-CHECK WAS RESTARTED. WITH THE ATTEMPT, THE PISTON SYRINGE STARTED TO LEAK FLUID FROM THE BLACK SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662404 ↗
• MalfunctionMar 19, 2025Sparking; Sparking

  IT WAS REPORTED THAT WHEN THE CORD WAS PLUGGED IN, IT SEEMED THAT THERE WAS A CRACKED. THE CUSTOMER STATED THAT THEY HAVE SEEN SPARKS COME FROM THE AREA. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21648533 ↗

Other Covidien LP products

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• LigaSure32 models · 7,283 reports · 1 recall
• Tri-Staple 2.037 models · 4,892 reports · 2 recalls
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• EEA39 models · 4,432 reports · 1 recall