EsoFLIP ES-330 (UDI 10884521809451)Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 10884521809451), received between Aug 18, 2021 and Jun 8, 2026 — classified as 9 injuries, 82 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (50 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 25, 2024Open, Classified

   Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.

   Z-2038-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT A CATHETER WAS FOUND TO HAVE AN UNIDENTIFIABLE MATTER DESCRIBED AS ¿SOMETHING FLOATING¿ IN THE PREFILLED SOLUTION INSIDE THE CATHETER, AND CONTAMINATION WAS ALSO OBSERVED INSIDE THE PACKAGING WITHOUT TOUCHING THE DEVICE. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND BIOLOGICAL CONTAMINATION HAS BEEN IDENTIFIED IN PRIOR SYRINGES CONTAINING PARTICULATE CONTAMINATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25430055 ↗
• MalfunctionApr 7, 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 24800977 ↗
• MalfunctionDec 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, BOTH CATHETERS FAILED PRE-USE CHECK. THE CUSTOMER TRIED THE PRE-USE CHECK TWICE ON EACH CATHETER. ANOTHER CATHETER FROM ANOTHER LOT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE SALINE WAS OUT OF SPECIFICATION.

  Patient problems: Insufficient Information

  MAUDE report 23861484 ↗
• MalfunctionDec 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, BOTH CATHETERS FAILED PRE-USE CHECK. THE CUSTOMER TRIED THE PRE-USE CHECK TWICE ON EACH CATHETER. ANOTHER CATHETER FROM ANOTHER LOT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE SALINE WAS OUT OF SPECIFICATION.

  Patient problems: Insufficient Information

  MAUDE report 23861480 ↗
• MalfunctionDec 18, 2025Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT, BOTH CATHETERS FAILED PRE-USE CHECK. THE CUSTOMER TRIED THE PRE-USE CHECK TWICE ON EACH CATHETER. ANOTHER CATHETER FROM ANOTHER LOT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE SALINE WAS OUT OF SPECIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835939 ↗
• MalfunctionDec 15, 2025Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT, BOTH CATHETERS FAILED PRE-USE CHECK. THE CUSTOMER TRIED THE PRE-USE CHECK TWICE ON EACH CATHETER. ANOTHER CATHETER FROM ANOTHER LOT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE SALINE WAS OUT OF SPECIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802177 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, A PATIENT EXPERIENCED AN ESOPHAGEAL PERFORATION AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT HAD EXTREME PAIN THAT DID NOT GET BETTER WITH PAIN MEDICINE AND DECREASED OXYGEN DEMAND. THE PERFORATION DIAGNOSED DUE TO BARIUM SWALLOW AND TREATED THROUGH ESOPHAGEAL STENT THEN SURGICAL INTERVENTION. THE CATHETER PASSED PRE-USE CHECK. THERE WAS NOTHING UNUSUAL ABOUT THE PROCEDURE. THE PATIENT WAS DISCHARGED ON (B)(6) 2025.

  Patient problems: Pain; Perforation of Esophagus

  MAUDE report 23742184 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO HOSPITAL A WEEK LATER WITH PERFORATION SYMPTOMS BUT NO TRUE PERFORATION NOTED. A COURSE OF ANTIBIOTICS, CONSERVATIVE MANAGEMENT WAS GIVEN. THE PATIENT DID WELL.

  Patient problems: Perforation of Esophagus

  MAUDE report 23465203 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO HOSPITAL A WEEK LATER WITH PERFORATION SYMPTOMS AND SIGNS OF ABSCESS AT CERVICAL LEVEL OF ESOPHAGUS. THE PATIENT HAD A POSSIBLE ABSCESS VERSUS FOCAL INFLAMMATION BUT NO TRUE PERFORATION NOTED. A COURSE OF ANTIBIOTICS, CONSERVATIVE MANAGEMENT WAS GIVEN. THE PATIENT DID WELL.

  Patient problems: Abscess; Perforation of Esophagus

  MAUDE report 23465115 ↗
• MalfunctionFeb 13, 2025Device Difficult to Setup or Prepare; Device Difficult to Program or Calibrate; Unable to Obtain Readings; Inadequacy of Device Shape and/or Size; Device Difficult to Setup or Prepare; Device Difficult to Program or Calibrate; Unable to Obtain Readings; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE REPORTER, THE CATHETER FAILED TO PRE USE CHECK, CATHETER WAS INFLATED HOWEVER THE PURGE WAS NOT SHOWING ON THE SCREEN. THE DIAMETERS DID NOT CHANGE AND THE INFLATE/DEFLATE COULD NOT BE VISUALIZED ON THE SCREEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381751 ↗
• MalfunctionFeb 13, 2025Application Program Problem; Application Program Problem

  ACCORDING TO THE REPORTER, AN ERROR MESSAGE CATHETER NOT SUPPORTED BY THIS SOFTWARE VERSION WAS NOTED WHEN TRYING TO COMPLETE THE PRE-USE CHECK. RESTARTING THE SYSTEM DID NOT RESOLVE THE ISSUE AND CONTINUE TO GET THE SAME ERROR. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381743 ↗
• MalfunctionFeb 13, 2025Application Program Problem; Application Program Problem

  ACCORDING TO THE REPORTER, THE CATHETER WAS NOT RECOGNIZE BY THE SOFTWARE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381721 ↗
• MalfunctionAug 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE CATHETER WAS ON RECALL AND WILL BE RETURNED. 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 20007813 ↗
• MalfunctionJun 27, 2024Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  ACCORDING TO THE REPORTER, THE CATHETER FAILED PRECHECK. EACH SENSOR WAS STUCK ON 7.6 DURING PRECHECK AND DID NOT MOVE EVEN THOUGH THE FILL VOLUME WAS CHANGING. MEDTRONIC¿S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT IF THE MIXING OF SALINE SOLUTION DURING THE MANUFACTURING PROCESS IS NOT HOMOGENEOUS, THE SALINE SOLUTION WILL GIVE A CONDUCTIVITY OUT OF RANGE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625500 ↗
• MalfunctionJun 27, 2024Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  ACCORDING TO THE REPORTER, THE CATHETER WAS BEING PREPARED FOR PROCEDURE AND FAILED PRE-USE CHECK AT THE END OF THE PURGE. AFTER FAILURE, IT WAS PURGED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624741 ↗
• MalfunctionJun 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, A BOX OF CATHETERS TURNED IN DUE TO RECALL. MEDTRONIC¿S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT IF THE MIXING OF SALINE SOLUTION DURING THE MANUFACTURING PROCESS IS NOT HOMOGENEOUS, THE SALINE SOLUTION WILL GIVE A CONDUCTIVITY OUT OF RANGE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19617200 ↗
• MalfunctionJun 19, 2024Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  ACCORDING TO THE REPORTER, THE CATHETER FAILED PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19568705 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A 63-YEAR OLD HAS HAD DYSPHAGIA. SHE HAD PREVIOUS ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATION. THE PATIENT WAS INFORMED OF THE HIGHER RISK, INCLUDING PERFORATION FOR THIS PROCEDURE. THE PROCEDURE WAS PERFORMED WITH 30MM DILATING BALLOON UNDER ENDOSCOPIC GUIDANCE. THE MAXIMUM DILATION DIAMETER OF THE FUNDOPLICATION REACHED 27MM. UPON DEFLATING THE BALLOON, THERE WAS A LARGE MUCOSAL TEAR OF THE MUCOSA IN THE DISTAL ESOPHAGUS. THE PATIENT REQUIRED ADMISSION FOR 12 DAYS AND AN ESOPHAGEAL STENT REPLACEMENT.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 19510556 ↗
• MalfunctionMay 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, A BOX OF 5 CATHETERS TURNED IN DUE TO RECALL. THE ABNORMAL D-EST VALUES WAS CONDUCTED, AND IT WAS FOUND THAT IF THE MIXING OF SALINE SOLUTION DURING THE MANUFACTURING PROCESS IS NOT HOMOGENEOUS, THE SALINE SOLUTION WILL GIVE A CONDUCTIVITY OUT OF RANGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19377010 ↗
• MalfunctionMay 14, 2024Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  ACCORDING TO THE REPORTER, THE CATHETER CALIBRATION/PRE USE CHECK WAS STARTED. AFTER CHECK MESSAGE WAS APPEARED "CATHETER CALIBRATION FAILED". THE CATHETER WAS REMOVED FROM THE SYSTEM THEN REINSERTED AND STARTED THE PRE USE CHECK AGAIN BUT THE SAME ERROR MESSAGE APPEARED. THE EXACT SAME STEPS WERE REPEATED FOR A SECOND CATHETER AND THE SAME MESSAGE APPEARED. TRIED A THIRD CATHETER FROM A DIFFERENT BOX AND LOT NUMBER, THE THIRD CATHETER CALIBRATED WITHOUT ISSUE AND WORKED FINE IN THE PATIENT AND THE DILATATION WAS COMPLETED. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309520 ↗
• MalfunctionMay 13, 2024Inflation Problem; Leak/Splash; Material Deformation; Inflation Problem; Leak/Splash; Material Deformation

  ACCORDING TO THE REPORTER, ALL 4 CATHETERS DID NOT INFLATE, AND DID NOT DISPLAY DATA ON THE SCREEN AND SOME WERE LEAKING. THE CUSTOMER PULLED ANOTHER UNIT FROM A DIFFERENT BOX AND CONTINUED WITHOUT ISSUE. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305784 ↗
• MalfunctionMay 13, 2024Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  ACCORDING TO THE REPORTER, A BOX OF CATHETER FAILED PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305638 ↗
• MalfunctionMay 13, 2024Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  ACCORDING TO THE REPORTER, THE CATHETERS FAILED PRECHECK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305395 ↗
• MalfunctionMay 13, 2024Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  ACCORDING TO THE REPORTER, A BOX OF CATHETER FAILED PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19304826 ↗
• MalfunctionMay 13, 2024Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  ACCORDING TO THE REPORTER, A BOX OF CATHETER FAILED PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19304449 ↗