EndoFLIP EF-322N (UDI 10884521809413)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521809413), received between Dec 20, 2022 and Jun 9, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJan 29, 2025

  DEVICE PASSED INITIAL SETUP TEST, INFLATED BALLOON BEFORE PROCEDURE AND WOULD NOT DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21262943 ↗
• MalfunctionDec 5, 2024

  CATHETER PASSED TEST PRIOR TO USE, DURING PROCEDURE WHEN INSERTED INTO THE ESOPHAGUS AND INFLATED, BALLOON INFLATED BUT WOULD NOT REGISTER PRESSURE. AFTER SEVERAL ATTEMPTS, ANOTHER CATHETER WAS OPENED AND SET UP. THE NEWLY OPENED CATHETER FUNCTIONED APPROPRIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852356 ↗
• MalfunctionDec 5, 2024

  ENDOFLIP MEASUREMENT CATHETER (MODEL #322N) FAILED UPON SET UP, DURING CALIBRATION ERROR CODE WAS GIVEN ON MONITOR. UNABLE TO USE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852329 ↗
• MalfunctionMay 28, 2024

  CATHETER LEAKING WATER DURING PRIMING/CHECKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19403800 ↗
• MalfunctionMay 7, 2024

  DURING ENDOFLIP PROCEDURE (THE FUNCTIONAL LUMEN IMAGING PROBE (FLIP) WITH A VOLUME BASED BAROSTAT BAG), WAS PLACED AT THE LOWER ESOPHAGEAL SPHINCTER FOR THE POST-INTERVENTION ASSESSMENT OF ACHALASIA. THE BAROSTAT BAG/BALLOON WAS INFLATED WHILE INSERTED, BUT DID NOT REGISTER PRESSURES. ABLE TO OBTAIN MEASUREMENTS WITH THIS PARTICULAR BALLOON ONCE, BUT THE SECOND TIME IT DID NOT OPERATE PROPERLY. ANOTHER FLIP AND BALLOON WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258845 ↗
• MalfunctionMay 7, 2024

  PRIOR TO USING IN PROCEDURE, ENDOFLIP BALLOON WOULD NOT ZERO. NEW BALLOON WAS USED INSTEAD WITH NO PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258762 ↗
• MalfunctionSep 13, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  ACCORDING TO THE REPORTER, THE TIP OF THE CATHETER FELL OFF OF THREE CATHETERS FROM THE SAME LOT NUMBER. ONE TIP CAME OFF IN THE PATIENT AND THE PATIENT COUGH IT UP. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: Cough

  MAUDE report 17740767 ↗
• MalfunctionApr 14, 2023Therapeutic or Diagnostic Output Failure

  PRE-CHECK OF THE CATHETER FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742570 ↗
• MalfunctionJan 31, 2023Pressure Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, RN NOTED THE PRESSURE READING FOR THE ENDO FLIP BALLOON WAS READING ABNORMALLY HIGH AT 200. THE PRESSURE READING SHOULD HAVE BEEN 20 OR BELOW. RN NOTIFIED THE PHYSICIAN OF THE PRESSURE READING. THE DECISION WAS MADE TO STOP THE PROCEDURE AND OBTAIN A NEW ZERO-PRESSURE READING WITH THE CURRENT CATHETER. THE PRESSURE READING DIDN'T CHANGE AFTER HAVING THE MACHINE CALCULATE ZERO PRESSURE A SECOND TIME. ENDO FLIP CATHETER WAS REMOVED FROM SERVICE. A NEW CATHETER WAS OBTAINED AND THE PROCEDURE CONTINUED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16271168 ↗
• MalfunctionJan 31, 2023Failure to Calibrate

  NEW ENDO FLIP 16CM NASAL TIP CONNECTED TO ENDO FLIP MACHINE. WOULD NOT CALIBRATE, MD STATES THAT IT WAS A PROBE FAILURE AND TO REMOVE IT FROM SERVICE. THIS OCCURRED BEFORE THE PATIENT ENTERED THE PROCEDURE ROOM. ANOTHER NEW ENDO FLIP 16CM NASAL TIP WAS OBTAINED FOR THE PROCEDURE AND CALIBRATED APPROPRIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16270980 ↗
• MalfunctionJan 31, 2023Failure of Device to Self-Test

  ENDOFLIP 16CM NASAL TIP BALLOON CATHETER DID NOT PASS PRECHECK. FAILED EQUIPMENT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16270947 ↗
• MalfunctionDec 20, 2022Defective Device

  IT WAS REPORTED THAT WHILE SETTING UP THE ENDOFLIP CATHETER 16CM NASAL TIP FOR USE DURING THE PROCEDURE, THE MEDTRONIC ENDOFLIP MACHINE NOTED THE CATHETER TO BE DEFECTIVE DURING THE INITIAL DIAGNOSTIC ANALYSIS. THE CATHETER WAS REMOVED FROM THE MACHINE AND A NEW CATHETER WAS PLACED.

  Patient problems: Insufficient Information

  MAUDE report 16014111 ↗