EsoFLIPRecalls & reported problems across all models

We found 3 models of EsoFLIP by Covidien LP in the FDA's device registry (GUDID). Together they are named in 100 adverse event reports in the FDA's MAUDE database, received between Jun 15, 2017 and Jun 8, 2026 — classified as 16 injuries, 84 malfunctions.

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

EsoFLIP 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. 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 · Recall details · FDA record ↗

Most reported EsoFLIP problems

EsoFLIP models

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

• EsoFLIP ES-330

  esophageal dilator balloon with or without electrode sensors
  1 recall91 reports
• EsoFLIP ES-330

  Esophageal Dilator With Balloon And Electrode Sensors
  8 reports
• EsoFLIP ES-320

  esophageal dilator with balloon and electrode sensors
  1 report

Recent EsoFLIP adverse event reports

The 15 most recent reports across all models, 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 ↗

Other Covidien LP products

• Endo GIA48 models · 26,277 reports · 8 recalls
• Endo GIA Ultra3 models · 15,650 reports
• Shiley387 models · 9,392 reports · 5 recalls
• Signia16 models · 8,201 reports · 6 recalls
• LigaSure32 models · 7,283 reports · 1 recall
• Tri-Staple 2.037 models · 4,892 reports · 2 recalls
• Polysorb291 models · 4,564 reports · 2 recalls
• EEA39 models · 4,432 reports · 1 recall