Skip to content

Maxi-Therm®Lite 874Recalls & reported problems

Gentherm Medical, LLC · Hyper-Hypothermia Blanket · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 20613031828747), received between Jul 27, 2018 and Jul 27, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Application Program 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 16, 2026.

Most reported problems

Device problems

  • Application Program Problem1
  • Temperature Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJul 27, 2018Application Program Problem; Temperature Problem

    COOLING BLANKET WAS BEING USED AS PART OF TOTAL BODY COOLING SYSTEM. BLANKET MALFUNCTIONED AND DID NOT MAINTAIN THE PROGRAMMED TEMPERATURE. COOLING BLANKET WAS REMOVED AND REPLACED BY A NEW COOLING BLANKET.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7725932 ↗

Other Pack, Hot Or Cold, Water Circulating devices

All Pack, Hot Or Cold, Water Circulating devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page