Bair Hugger™ 63500Recalls & reported problems
3m Company · 3M™ Bair Hugger™ Full Access Underbody Blanket, 10 per case, 63500 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 50707387775129), received between Jan 30, 2018 and Jan 30, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Device Issue” (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 18, 2026.
Most reported problems
Device problems
- Device Issue1
- Improper Device Output1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- Hypothermia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 30, 2018Device Issue; Improper Device Output; Therapeutic or Diagnostic Output Failure; Device Issue; Improper Device Output; Therapeutic or Diagnostic Output Failure
PATIENT WENT INTO HYPOTHERMIA AFTER USE OF A WARMING BLANKET. THE PATIENT'S HYPOTHERMIA TEMPERATURE WAS AT 35.2°C. THIS PATIENT WAS PREVIOUSLY OPERATED FOR AN ENDOLUMINAL MITRAL VALVE. THEN, IN POST-OPERATIVE PHASE, THE PATIENT HAD TO BE MAINTAINED UNDER ANESTHESIA AND SENT TO THE INTENSIVE CARE UNIT UNTIL RECOVERY OF A NORMAL BODY TEMPERATURE. IT WAS OBSERVED THE LEFT LATERAL BOLSTER SEAL TO THE DISTAL END OF THE BLANKET DID NOT ALLOW FOR AIR CIRCULATION IN THE AREA OF THE PATIENT'S LEGS AND ALONG SIDE THE PATIENT'S BODY WHICH RESULTED IN A LACK OF WARMING.
Patient problems: Hypothermia
MAUDE report 7229320 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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