Blanketrol® lll 233Recalls & reported problems
Gentherm Medical, LLC · Thermal Regulating System · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10613031861075), received between Nov 9, 2023 and Jul 28, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Overheating of Device4
- Electrical /Electronic Property Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Hyperthermia1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2026Overheating of Device
The customer claims that the device has power to the switch but no display.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50057728 ↗MalfunctionJul 28, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50054665 ↗MalfunctionJul 28, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50052871 ↗MalfunctionJul 28, 2026Overheating of Device
The customer claims that the CPU board has melted solder on the F4 fuse.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50052292 ↗MalfunctionOct 23, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CUSTOMER REPORTED THAT THIS DEVICE WAS BLOWING FUSES. UPON DEVICE EVALUATION, IT WAS OBSERVED THAT THERE WAS DISCOLORATION AROUND THE F1 FUSE ON THE CONTROL BOARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368646 ↗MalfunctionNov 9, 2023
DURING BEDSIDE HANDOFF PATIENT'S TEMPERATURE NOTED TO BE 104.5 DEGREES FAHRENHEIT. BLANKETROL READ THAT THE WATER TEMPERATURE WAS 40 DEGREES FAHRENHEIT AND APPEARED TO BE IN WORKING ORDER. THE REPRESENTATIVE NOTICED THAT THE FAN ON THE BLANKETROL MACHINE WAS NOT FUNCTIONING PROPERLY AND THE WATER BEING DELIVERED TO THE COOLING DEVICE WAS WARM DESPITE THE BLANKETROL DISPLAYING THAT IT WAS DELIVERING WATER AT 40 DEGREES FAHRENHEIT. MACHINE WAS EXCHANGED AND NEW MACHINE WAS NOTED BE WORKING CORRECTLY. PATIENT'S TEMPERATURE IMPROVED AFTERWARDS.
Patient problems: Hyperthermia
MAUDE report 18102252 ↗
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- HotDog Temperature Management System WC77Augustine Temperature Management LLC · System, Thermal Regulating2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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