Mul-T-Blanket 8001-061-810Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327175066), received between Oct 1, 2020 and Apr 17, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE CUSTOMER ALLEGED THEY HAD AN ISSUE WITH THE ITEM BURSTING. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862245 ↗
• MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS SPRAYING WATER FROM THE BLANKET (LIQUID LEAKS ONTO THE PATIENT SURFACE). NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19043746 ↗
• MalfunctionOct 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE HYPER/HYPO COOLING/WARMING BLANKET BEGINS TO LEAK WHILE IN PATIENT USE. THE BLANKET IS NOT LEAKING FROM THE CONNECTION SITE, BUT RATHER APPEARS TO HAVE HOLES IN THE MAIN BLANKET MATERIAL. THE PATIENT WAS NOT ADVERSELY AFFECTED AND NO CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10614049 ↗
• MalfunctionOct 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE HYPER/HYPO COOLING/WARMING BLANKET BEGINS TO LEAK WHILE IN PATIENT USE. THE BLANKET IS NOT LEAKING FROM THE CONNECTION SITE, BUT RATHER APPEARS TO HAVE HOLES IN THE MAIN BLANKET MATERIAL. THE PATIENT WAS NOT ADVERSELY AFFECTED AND NO CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10614044 ↗
• MalfunctionOct 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE HYPER/HYPO COOLING/WARMING BLANKET BEGINS TO LEAK WHILE IN PATIENT USE. THE BLANKET IS NOT LEAKING FROM THE CONNECTION SITE, BUT RATHER APPEARS TO HAVE HOLES IN THE MAIN BLANKET MATERIAL. THE PATIENT WAS NOT ADVERSELY AFFECTED AND NO CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10614043 ↗
• MalfunctionOct 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE HYPER/HYPO COOLING/WARMING BLANKET BEGINS TO LEAK WHILE IN PATIENT USE. THE BLANKET IS NOT LEAKING FROM THE CONNECTION SITE, BUT RATHER APPEARS TO HAVE HOLES IN THE MAIN BLANKET MATERIAL. THE PATIENT WAS NOT ADVERSELY AFFECTED AND NO CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10614041 ↗