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EnsoETM ECD01-A (UDI 00857915006166)Recalls & reported problems

Advanced Cooling Therapy, LLC · The EnsoETM is a thermal regulating device, intended to connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature, connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures, and and provide gastric decompression and suctioning. The EnsoETM is packaged with a universal bite block and lubrication jelly. · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857915006166), received between Aug 28, 2018 and Aug 28, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Cooling” (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

  • Insufficient Cooling1

Patient problems

  • Alteration In Body Temperature1

Recent adverse event reports

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

  • MalfunctionAug 28, 2018Insufficient Cooling

    PATIENT IS ADMITTED STATUS POST CARDIAC ARREST. MD ORDERED HYPOTHERMIA PROTOCOL TO BE APPLIED. OBTAINED COOLING WRAPS/BLANKET WITH A GOAL TEMP OF 36. COOLING BLANKET STATES IT IS COOLING PATIENT WITH A WATER TEMPERATURE OF 27. COOLING BLANKET FEELS AS THOUGH IT IS ROOM TEMPERATURE, AND THE PATIENT'S TEMP CONTINUED TO RISE.

    Patient problems: Alteration In Body Temperature

    MAUDE report 7822183 ↗

Other Esophageal Thermal Regulation And Gastric Suctioning Device devices

All Esophageal Thermal Regulation And Gastric Suctioning Device devices →

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