EnsoETM ECD02-A (UDI 00857915006180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00857915006180), received between Apr 7, 2022 and Mar 5, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A LEFT ATRIAL ABLATION PROCEDURE ON MONDAY, (B)(6) 2024. THE ENSOETM WAS PLACED SUCCESSFULLY WITHOUT DIFFICULTY, AND PROPER POSITION WAS CONFIRMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AT THE TIME OF PLANNED DISCHARGE THE NEXT MORNING, THE PATIENT FELT LIGHTHEADED, PROMPTING ADDITIONAL WORKUP. THE PATIENT'S HEMOGLOBIN WAS FOUND TO BE LOW (4.9 G/DL, FROM A PREVIOUS LEVEL OF 12 G/DL), BUT THE PATIENT DID NOT HAVE HEMATEMESIS, MELENA, OR ANY OTHER ADDITIONAL SYMPTOMS AT THIS TIME. A CT ANGIOGRAM OF CHEST, ABDOMEN, AND PELVIS WAS NEGATIVE FOR ANY ETIOLOGY. THE PATIENT RECEIVED A TRANSFUSION OF A TOTAL OF 5 UNITS OF PACKED RED BLOOD CELLS AND SUBSEQUENTLY DEVELOPED MELANOTIC STOOLS, BUT DID NOT EXPERIENCE ANY HEMATEMESIS. ON (B)(6) 2024, AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS PERFORMED WHICH SHOWED A SUPERFICIAL ULCER AT THE DISTAL THIRD OF THE ESOPHAGUS WITH STIGMATA OF RECENT BLEEDING, AND BLOOD IN THE STOMACH. THE LOCATION OF THE LESION IN RELATION TO ANTERIOR/POSTERIOR DIMENSION OF THE ESOPHAGUS WAS UNCERTAIN ON INITIAL IMAGING, AND GASTROENTEROLOGY COULD NOT DEFINE THE CIRCUMFERENTIAL LOCATION OF THE LESION. THE SITE HAD NO ACTIVE BLEEDING VISIBLE, BUT A

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 18842104 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A RADIOFREQUENCY CARDIAC ABLATION PROCEDURE TO TREAT THEIR ATRIAL FIBRILLATION ON (B)(6) 2023. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA AND WAS INTUBATED WITH A STANDARD ENDOTRACHEAL TUBE. INTUBATION WAS PERFORMED BY A TRAINEE WHO EXPERIENCED DIFFICULTY COMPLETING THE INTUBATION AND REQUIRED MULTIPLE ATTEMPTS TO PLACE THE ENDOTRACHEAL TUBE. THE ENSOETM WAS SUCCESSFULLY PLACED INTO THE ESOPHAGUS WITHOUT DIFFICULTY, AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. UPON WITHDRAWAL OF THE ENSOETM AFTER THE END OF THE PROCEDURE, A SMALL AMOUNT OF BLOOD WAS DISCOVERED IN THE OROPHARYNX. THE SOURCE OF THE BLOOD WAS UNCLEAR, BUT IT WAS INITIALLY PRESUMED TO BE FROM OROPHARYNGEAL TRAUMA FROM THE DIFFICULT INTUBATION. AS A RESULT, THE CLINICAL TEAM ELECTED TO KEEP THE PATIENT ENDOTRACHEALLY INTUBATED WHILE FURTHER EVALUATION WAS UNDERTAKEN IN THE INTENSIVE CARE UNIT (ICU). IN THE ICU OVER THE FOLLOWING DAY, THE PATIENT HAD A CT SCAN OF THE CHEST, SHOWING A DIFFUSELY THICKENED ESOPHAGUS SUGGESTIVE OF ESOPHAGITIS. AN ENDOSCOPY SHOWED EVIDENCE OF OROPHARYNGEAL TRAUMA, BUT WITHOUT A CLEAR SOURCE OF ANY BLEEDING AND NO ESOPHAGEAL PERFORATION. IN THE DISTAL ESOPHAGUS

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 18093050 ↗
• InjuryFeb 17, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT UNDERWENT A RADIOFREQUENCY CARDIAC ABLATION PROCEDURE FOR ATRIAL FIBRILLATION AND ATRIAL FLUTTER ON (B)(6) 2023, AND THE ENSOETM WAS USED TO COOL THE ESOPHAGUS DURING THE PROCEDURE. THE PATIENT WAS INTUBATED WITH AN ENDOTRACHEAL TUBE AT APPROXIMATELY 7:58AM LOCAL TIME, AND THE ENSOETM WAS PLACED AT APPROXIMATELY 8:27AM. AT APPROXIMATELY 11:00AM, TOWARDS THE END OF THE CASE, IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE HAD DECREASED FROM A SYSTOLIC PRESSURE ABOVE 80MMHG TO A SYSTOLIC PRESSURE BELOW 60MMHG. IMAGING ON INTRACARDIAC ECHOCARDIOGRAPHY SHOWED DECREASED VENTRICULAR CONTRACTILITY, PROMPTING THE ADMINISTRATION OF APPROXIMATELY 45 SECONDS OF CARDIOPULMONARY RESUSCITATION, ALONG WITH THE ADMINISTRATION OF AN EPINEPHRINE DRIP. THE PATIENT'S VITAL SIGNS IMPROVED, AND SHE WAS TRANSFERRED TO THE INTENSIVE CARE UNIT, WHERE A FOLEY CATHETER WITH TEMPERATURE MONITORING CAPABILITY WAS PLACED, SHOWING A TEMPERATURE OF 31°C. UPON REVIEW OF ANESTHESIA RECORDS, IT WAS DISCOVERED THE PATIENT REACHED A MINIMUM TEMPERATURE OF 29°C. HOWEVER, THE SOURCE OF THIS TEMPERATURE MEASUREMENT (WHETHER FROM NASOPHARYNGEAL, FOREHEAD, AXILLARY, ETC.) WAS NOT RECORDED, AND THE MINIMUM TEMPER

  Patient problems: Hypothermia

  MAUDE report 16401097 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A RADIOFREQUENCY CARDIAC ABLATION PROCEDURE FOR ATRIAL FIBRILLATION ON (B)(6) 2022 THAT UTILIZED THE ENSOETM TO COOL THE ESOPHAGUS DURING THE PROCEDURE. PRIOR TO THE PROCEDURE, AN ENDOTRACHEAL TUBE WAS USED TO SECURE THE PATIENT'S AIRWAY, AND PLACEMENT OF THE ENDOTRACHEAL TUBE INTO THE TRACHEA WAS NOTED TO BE DIFFICULT. THE INITIAL ATTEMPT AT PLACEMENT OF THE ENDOTRACHEAL TUBE MET RESISTANCE AND WAS STOPPED. MULTIPLE OPERATORS (INCLUDING A STUDENT CRNA, CRNA, AND ANESTHESIOLOGIST) ATTEMPTED PLACEMENT, AND MULTIPLE ATTEMPTS WERE REQUIRED. ANESTHESIA NOTES STATED THAT DIRECT LARYNGOSCOPY OFFERED ONLY A GRADE 3 VIEW IN THE CORMACK-LEHANE CLASSIFICATION (WHERE GRADING RANGES FROM I TO 4 WITH INCREASING DIFFICULTY OF VIEW OF THE GLOTTIS). ONCE ENDOTRACHEAL TUBE PLACEMENT WAS SUCCESSFUL, THE ENSOETM (OUR DEVICE) WAS INSERTED WITHOUT DIFFICULTY INTO THE ESOPHAGUS. THE PATIENT WAS IN THE PROCEDURE ROOM BY 11:21AM LOCAL TIME, THE ENSOETM WAS PLACED AROUND 11:45AM IN THE ESOPHAGUS, ACCESS WAS OBTAINED AT 12:05PM, CASE COMPLETION WAS AT 2:04PM, PATIENT EXTUBATION WAS AT 2:13PM, AND THE PATIENT WAS OUT OF THE ROOM BY 2:29PM. POST-OPERATIVELY, THE PATIENT NOTED 10/10 PERIU

  Patient problems: Hematoma

  MAUDE report 16260226 ↗
• InjuryApr 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE PATIENT RECEIVED A RADIOFREQUENCY CARDIAC ABLATION PROCEDURE FOR ATRIAL FIBRILLATION ON (B)(6) 2022. AN ENSOETM WAS INSERTED TO THE COOL THE PATIENT'S ESOPHAGUS DURING THE PROCEDURE. THE DEVICE WAS INSPECTED FOR LEAKS PRIOR TO INSERTION, AND NO LEAKS WERE NOTED PRIOR TO INSERTION. AFTER INSERTION, A SMALL AMOUNT OF FLUID WAS NOTED IN THE PATIENT'S MOUTH. AT THIS TIME, THE ENSOETM WAS PARTIALLY REMOVED FROM THE ESOPHAGUS AND INSPECTED FOR LEAKS, AND A "SMALL TRICKLE" OF WATER WAS NOTED. HOWEVER, THIS FLUID WAS INITIALLY BELIEVED TO BE ORAL SECRETIONS FROM THE MOUTH AND THE ENSOETM WAS REPLACED. UPON RE-INSERTING THE ENSOETM IN THE ESOPHAGUS, MORE FLUID WAS NOTED IN THE PATIENT'S MOUTH, AND THE ENSOETM WAS AGAIN REMOVED AND INSPECTED FOR LEAKS. AT THIS TIME, A STEADY STREAM OF WATER WAS NOTED TO BE LEAKING FROM THE SIDE OF THE TUBE NEAR THE LOCATION ON THE DEVICE WHERE THE PATIENT'S MOUTH WAS LOCATED. THE LEAKING ENSOETM WAS REPLACED WITH A NEW ENSOETM, AND THE REMAINDER OF THE ABLATION PROCEDURE PROCEEDED WITHOUT INCIDENT. FOLLOWING THE PROCEDURE, THE PATIENT WAS HELD IN THE HOSPITAL TO ALLOW A SUFFICIENT NUMBER OF HEMODIALYSIS SESSIONS TO RESTORE THE PATIENT TO THEIR OPTIMAL WE

  Patient problems: Hypervolemia

  MAUDE report 14048358 ↗