WarmTouch 5016000Recalls & reported problems
Covidien LP · Convective Warming Unit · Class 2
Quick summary
This Covidien WarmTouch convective warming unit has 80 reports. They mostly describe temperature problems—overheating, alarms, and smoke odors—sometimes causing burns. There are no deaths and 2 injuries. There are no recalls naming this device. Reports fell from 16 in the prior 12 months to 2 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 82
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10884521141100), received between Jan 5, 2018 and Sep 30, 2026 — classified as 2 injuries, 80 malfunctions.
The most frequently reported specific device problem is “Temperature Problem” (35 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Temperature Problem35
- Device Alarm System21
- Image Display Error/Artifact10
- High Readings9
- Insufficient Heating8
- Failure to Power Up7
- Low Readings6
- Patient Device Interaction Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- Insufficient Information12
- No Patient Involvement8
- Burn(s)5
- No Consequences Or Impact To Patient4
- Burn, Thermal1
- Skin Burning Sensation1
- Skin Irritation1
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Temperature Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954957 ↗MalfunctionSep 25, 2026Temperature Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904134 ↗MalfunctionMay 4, 2026High Readings
IT WAS REPORTED THAT THE TEMPERATURE OF THE WARMING UNIT WAS INCREASING AND THEN STOPPED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074346 ↗MalfunctionApr 1, 2026Image Display Error/Artifact; Temperature Problem
IT WAS REPORTED THAT, DURING SERVICING, THE WARMING UNIT HAD A YELLOW TRIANGLE ALARM. THERE WAS NO SMOKE OR FIRE. THE INTERNAL CONNECTORS AND CABLES WERE PHYSICALLY BURNT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24760622 ↗MalfunctionJul 8, 2025Temperature Problem; Temperature Problem
IT WAS REPORTED THAT WHEN THE DEVICE WAS PLUGGED IN, THERE WAS A SMOKE ODOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22441510 ↗MalfunctionJun 30, 2025Device Alarm System; High Readings; Device Alarm System; High Readings
IT WAS REPORTED THAT DURING USE, THE UNIT WAS REACHING AROUND 55°C DESPITE BEING SET TO 40°C. THE SYSTEM DID NOT DISPLAY ANY ERROR OR WARNING. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 22355288 ↗MalfunctionJun 30, 2025Device Alarm System; High Readings; Patient Device Interaction Problem; Device Alarm System; High Readings; Patient Device Interaction Problem
IT WAS REPORTED THAT DURING USE, THE UNIT WAS REACHING AROUND 55°C DESPITE BEING SET TO 40°C. THE SYSTEM DID NOT DISPLAY ANY ERROR OR WARNING, WHICH RESULTED IN BURNS TO THE PATIENT.
Patient problems: Skin Burning Sensation
MAUDE report 22355264 ↗MalfunctionJun 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT DURING USE, THE UNIT EXHIBITED INCREASED HEAT, RESULTING IN A BURN INJURY TO THE PATIENT.
Patient problems: Burn(s)
MAUDE report 22352687 ↗MalfunctionJun 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT, DURING USE, THE UNIT HAD AN INCREASED HEAT CAUSING A BURN TO THE PATIENT.
Patient problems: Burn(s)
MAUDE report 22352669 ↗MalfunctionJun 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT DURING USE, THE UNIT EXHIBITED INCREASED HEAT, RESULTING IN A BURN INJURY TO THE PATIENT.
Patient problems: Burn(s)
MAUDE report 22352668 ↗MalfunctionJun 17, 2025Device Damaged Prior to Use; Defective Component; Component Missing; Temperature Problem; Device Damaged Prior to Use; Defective Component; Component Missing; Temperature Problem
IT WAS REPORTED THAT THE DEVICE HAD A BROKEN CASING, MISSING NOZZLE, AND THE POWER SUPPLY WAS BURNT. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 22243905 ↗MalfunctionMay 19, 2025Image Display Error/Artifact; High Readings; Image Display Error/Artifact; High Readings
IT WAS REPORTED THAT A HIGH TEMPERATURE ERROR WAS OBSERVED WITH THE UNIT. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COM PLICATIONS AS A RESULT OF THE EVENT.
Patient problems: Insufficient Information
MAUDE report 22044330 ↗MalfunctionMay 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THERE WAS A PATIENT BURN OCCURRED DUE TO THE BLANKET WITH 45" IN THE RECOVERY ROOM. THERE WERE TEMPERATURE MANAGEMENT DEVICES FROM VARIOUS MANUFACTURERS IN THE ROOM, IT WAS UNCLEAR WHICH DEVICE CAUSED THE BURN.
Patient problems: Burn(s)
MAUDE report 22043450 ↗MalfunctionMar 17, 2025Insufficient Heating; Image Display Error/Artifact; Device Damaged Prior to Use; Temperature Problem; Insufficient Heating; Image Display Error/Artifact; Device Damaged Prior to Use; Temperature Problem
IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE SHOWED A YELLOW TRIANGLE ALARM 10 MINUTES AFTER BEING TURNED ON, DID NOT HEAT THE AIR, AND ALSO HAD DAMAGED CARDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21622852 ↗InjuryJan 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A PATIENT USING A THERMAL BLANKET ON THE UPPER LIMBS, IN CONJUNCTION WITH THE WARMTOUCH HEATING EQUIPMENT, SUFFERED A THERMAL BURN ON THE RIGHT ARM. THE SURROUNDING AREA TURNED RED, AND THERE WERE TWO SPOTS, AS IF THE PATIENT'S SKIN WAS LOOSE. A SCALPEL WAS USED, AND THE AREA WAS CLEANED WITH ALCOHOLIC CHLORHEXIDINE. A CONSULTATION WITH A PLASTIC SURGEON DIAGNOSED THE INJURY AS A THERMAL BURN. THE HOSPITALIZATION WAS EXTENDED DUE TO THIS EVENT.
Patient problems: Burn(s)
MAUDE report 21167284 ↗MalfunctionNov 12, 2024Low Readings; Low Readings
ACCORDING TO THE REPORTER, PRIOR TO USE, THE PRODUCT'S TEMPERATURE WAS NOT ACHIEVED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20664931 ↗MalfunctionNov 8, 2024High Readings; Low Readings; High Readings; Low Readings
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE'S HIGHER TEMPERATURE ACCURACY WAS OFF. THE HIGH TEMPERATURE WAS 49C INSTEAD OF 47C, AND THE LOW TEMPERATURE WAS 35.6C. THE CUSTOMER FOLLOWED THE SERVICE MANUAL TO PERFORM THE TEMP TEST ON THE UNIT AND HAD TESTED 10 OTHER UNITS THAT WERE IN SPEC. THE CUSTOMER USED A FLUKE METER WITH A TYPE K THERMOCOUPLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20645408 ↗MalfunctionNov 6, 2024High Readings; High Readings
ACCORDING TO THE REPORTER, THE PRODUCT HAD VERY HIGH TEMPERATURE READINGS OUTSIDE THE PARAMETERS ALLOWED BY THE MANUFACTURER DURING THE FUNCTIONAL VERIFICATION TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20621852 ↗MalfunctionNov 6, 2024Low Readings; Low Readings
ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT WAS UNABLE TO ACHIEVE THE TARGET TEMPERATURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20621186 ↗MalfunctionNov 5, 2024High Readings; High Readings
ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD A HIGH-TEMPERATURE ALERT. IT WAS INDICATED THAT THERE WAS NO FIRE, SPARK OR SMOKE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20611783 ↗MalfunctionOct 7, 2024Insufficient Heating; Device Damaged Prior to Use; Failure to Calibrate; Temperature Problem; Insufficient Heating; Device Damaged Prior to Use; Failure to Calibrate; Temperature Problem
ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD A BROKEN CASE, WAS OVERHEATING, AND COULD NOT BE CALIBRATED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20384077 ↗MalfunctionSep 23, 2024Temperature Problem; Temperature Problem
ACCORDING TO THE REPORTER, DURING SERVICING, THE UNIT HAD BURNING CABLE SMELL. THERE WAS NO SMOKE OR FLAME AND IT TURNED OFF AUTOMATICALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20279523 ↗MalfunctionSep 20, 2024Device Alarm System; Device Alarm System
ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE THERMOSTAT WAS TESTED, THE DEVICE WAS NOT ALARMING EVEN AFTER TWO MINUTES DETERMINED BY THE MANUFACTURER. AFTER REPLACING THE THERMOSTAT, CABLE AND THE POWER BOARD, THE ERROR HAD BEEN FIXED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20273122 ↗MalfunctionSep 4, 2024Temperature Problem; Temperature Problem
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD A BURNED POWER BOARD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20137237 ↗MalfunctionAug 26, 2024Image Display Error/Artifact; Failure to Power Up; Temperature Problem; Image Display Error/Artifact; Failure to Power Up; Temperature Problem
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE DID NOT TURN ON AND HAD THE ERROR "BLANKET OVERHEAT, RESTART OR REPLACE UNIT." ( OVERHEATING). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20064653 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.