S-CATH™ Esophageal Temperature Probe CS-2001 (65cm Length)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10860237000214), received between Feb 24, 2022 and Aug 25, 2023 — classified as 1 death, 6 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2023Difficult to Insert; Difficult to Insert

  A PATIENT HAD A PERFORATION IN THEIR THROAT AND THEY THINK IT MAY BE FROM WHEN THE CRNA INTRODUCED THE PROBE.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 17627653 ↗
• InjuryMay 5, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PROCEDURE WAS ATRIAL FLUTTER/FIBRILLATION ABLATION. THE ATRIAL FLUTTER WAS ABLATED AND TRANSSEPTAL WAS PERFORMED. THE PATIENT'S BLOOD PRESSURE DROPPED SUDDENLY AND THE PROCEDURE WAS STOPPED. THE PATIENT WAS TRANSFERRED TO THE ICU. PATIENT HAD ECMO DONE LATER IN THE DAY. THE ABLATION IN THE LEFT ATRIUM HAD NOT PERFORMED AND CIRCA HAD NOT CLARIFIED ITS POSITION UNDER X-RAY PRIOR THE INCIDENT OCCURRENCE. ELECTROPHYSIOLOGIST STATED THAT THE CIRCA PROBE WAS PLACED IN THE BRONCHUS WHICH CAUSED HEMORRHAGE. ANESTHESIOLOGIST ASSISTANT STATED THAT THERE WAS NO EVIDENCE OF THE PATIENT'S BRONCHIAL HEMORRHAGE.

  Patient problems: Bronchial Hemorrhage

  MAUDE report 16881576 ↗
• DeathFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION (PVI) PROCEDURE, AN ESOPHAGEAL PERFORATION CAUSING SEPSIS IN THE PATIENT. THE TEMPERATURE MONITORING DEVICE WAS ALARMING ABOVE THE MANUFACTURER'S RECOMMENDED HIGH USAGE SUGGESTIONS. THE PATIENT WAS ADMITTED 17 DAYS POST PROCEDURE DUE TO SEPSIS CAUSED FROM AN ESOPHAGEAL PERFORATION THE (SIC) LIKELY OCCURRED DURING THE ABLATION PROCEDURE. PER CT: MEDIASTINUM AND LYMPHATIC, THERE WAS PNEUMOMEDIASTINUM, WITH AIR ANTERIOR TO THE ESOPHAGUS AT THE LEVEL OF THE RIGHT MAIN PULMONARY ARTERY, AND EXPENDING INFERIORLY ALONG THE POSTERIOR MARGIN OF THE LEFT ATRIUM. IT IS SUSPECTED TO ARISE FROM ESOPHAGEAL PERFORATION AT THE LEVEL OF THE MID ESOPHAGUS.

  Patient problems: Fistula

  MAUDE report 16390702 ↗
• InjuryMay 6, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DR. REPORTS A PATIENT LUNG PERFORATION CAUSED BY CIRCA PROBE. PATIENT COUGHED UP BLOOD FOR FIVE DAYS, THEN RECOVERED. NO FLUOROSCOPY WAS USED IN THE PROCEDURE.

  Patient problems: Perforation

  MAUDE report 14311657 ↗
• InjuryMay 6, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DR. REPORTS A PATIENT LUNG PERFORATION CAUSED BY CIRCA PROBE. PATIENT COUGHED UP BLOOD FOR FIVE DAYS, THEN RECOVERED. NO FLUOROSCOPY WAS USED IN THE PROCEDURE.

  Patient problems: Perforation

  MAUDE report 14311468 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN ASKED US TO REPORT THE OCCURRENCE OF A PATIENT WHO HAD AN ESOPHAGEAL FISULA FOLLOWING AN RF ABLATION. CIRCA WAS USED TO MONITOR ESOPHAGEAL TEMPERATURE. PATIENT HAS SINCE RECOVERED. TEE PROBE WAS ALSO USED ON PATIENT FOR WATCHMAN INSERTION.

  Patient problems: Fistula

  MAUDE report 13602629 ↗
• InjuryFeb 24, 2022Difficult to Insert; Difficult to Insert

  DURING PROBE INSERTION THEY ENCOUNTERED RESISTANCE. DOCTOR ALSO USES ESOSURE WITH AN OG TUBE. OG TUBE WAS INSERTED BEFORE CIRCA PROBE. TOWARD END OF CASE BLEEDING WAS NOTED. ENT WAS CALLED AND DIDN'T NOTE ANY DAMAGE.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 13595998 ↗