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Level 1 ES400-18Recalls & reported problems

Icu Medical, Inc. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30695085000321), received between May 12, 2017 and May 12, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Use of Device Problem1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 12, 2017Use of Device Problem; Use of Device Problem

    IT WAS REPORTED THAT A LEVEL 1® ESOPHAGEAL STETHOSCOPE TEMPERATURE SENSOR MIGRATED INTO THE PATIENT'S STOMACH. THE PATIENT WAS UNDERGOING A LAPAROSCOPIC GASTRIC SLEEVE SURGERY AT THE TIME OF THE EVENT. WHILE THE DOCTOR WAS STAPLING THE STOMACH (AS A PART OF THE GASTRIC SLEEVE SURGERY), THE DOCTOR STAPLED OVER THE ESOPHAGEAL STETHOSCOPE TEMPERATURE SENSOR; STAPLING THE DEVICE INTO THE PATIENT'S STOMACH. TO CORRECT THIS, THE PATIENT'S SURGERY HAD TO BE CONVERTED TO AN "OPEN" PROCEDURE, REQUIRING A FULL OPENING OF THE PATIENT'S ABDOMEN. THE EVENT ITSELF WAS DETERMINED TO BE AN OPERATOR ERROR. IT WAS REPORTED THAT THERE WERE NO FURTHER CLINICAL CONSEQUENCES TO THE PATIENT.

    Patient problems: Foreign Body In Patient

    MAUDE report 6563648 ↗

Other STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS devices

All STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.