MEDLINE MDSCC20Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10193489079449), received between Sep 8, 2026 and Sep 30, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  It was reported that "Order 7 but 2 are defective & leaking." When asked what is leaking on the unit, the customer stated, "The connection from the pad to the hose."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946234 ↗
• MalfunctionSep 24, 2026Fluid/Blood Leak

  It was reported that "This item is leaking at the seals."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884653 ↗
• MalfunctionSep 11, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50739123 ↗
• MalfunctionSep 11, 2026Electrical /Electronic Property Problem

  It was reported that the water is not circulating to the pad. The unit would work intermittently, but sometimes the water would get hot, in the 90s F.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733289 ↗
• MalfunctionSep 8, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676779 ↗