ESOPHASTAR F8ENNNNHSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835008227), received between Apr 5, 2022 and Oct 9, 2023 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE USING AN UNKNOWN ESOPHASTAR. THE PATIENT EXPERIENCED EPIGASTRIC DISCOMFORT POST PROCEDURE AND THE PATIENT ULTIMATELY ENDED UP PASSING AWAY. THE PATIENT UNDERWENT A CRYOAFIB (CRYO ATRIAL FIBRILLATION) CASE. THE PATIENT PASSED AWAY AFTER HAVING STOMACH PAINS. BEYOND SOME DIFFICULTY GETTING ACCESS TO THE GROIN, THE MEDICAL TEAM DID NOT ENCOUNTER PROCEDURAL COMPLICATIONS. THIS EVENT IS BEING CAPTURED ON THE ESOPHASTAR AS A CONSERVATIVE MEASURE UNTIL FURTHER INFORMATION IS PROVIDED ABOUT THE CAUSE OF DEATH IN THIS PATIENT. THE ESOPHASTAR IS ASSOCIATED WITH THE ESOPHAGUS WHICH CAN BE RELATED TO THE PATIENT'S EPIGASTRIC PAIN.

  Patient problems: Heartburn/Indigestion

  MAUDE report 17901895 ↗
• InjuryApr 5, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT (AVERAGE BUILD, EXACT WEIGHT UNKNOWN) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN ESOPHASTAR¿ ESOPHAGEAL MAPPING CATHETER. THE PATIENT HAD SIGNIFICANT BLEEDING FROM THE SOFT PALATE TOWARDS THE BACK OF THE NOSE. THE PATIENT SUFFERED AN ESOPHAGEAL BLEEDING THAT STATED WHEN THEY WERE ABLATING IN THE LEFT ATRIUM. THE BLEEDING WAS SEEN FROM THE PATIENT MOUTH AROUND THE ESOPHASTAR¿ ESOPHAGEAL MAPPING CATHETER. THEY HALTED THE PROCEDURE AND REVERSED THE HEPARIN. ABOUT 200 ML OF BLOOD WAS REMOVED FROM THE ESOPHAGUS. THE PATIENT IS STABLE AND THEY ARE WAITING TO SEE IF THE BLEEDING STOPS. IT IS BELIEVED THAT THE ISSUE WAS CAUSED BY THE ESOPHASTAR¿ ESOPHAGEAL MAPPING CATHETER. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS IT EVENTUALLY WAS DETERMINED TO BE ABOVE THE SOFT PALATE TOWARDS THE BACK OF THE NOSE. CAUSE WAS DETERMINED TO BE FROM STICKING THE TEMPERATURE PROBE THROUGH THE NOSE. THE ANESTHESIOLOGIST HAD OUR ESOPHASTAR¿ ESOPHAGEAL MAPPING CATHETER TAPED TO THE TEMPERATURE PROBE AT ONE POINT DURING THE PROCEDURE. SHE DID NOT CONFIRM WHETHER IT WAS STILL ATTACHED AT TIME OF INJURY OR NOT. AS THIS WAS A CR

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Tissue Injury

  MAUDE report 14015127 ↗