NAMIC 613000121Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10193489074475), received between Sep 23, 2026 and Sep 30, 2026 — classified as 4 malfunctions.

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948918 ↗
• MalfunctionSep 28, 2026Fluid/Blood Leak

  It was reported that "We have experienced leaking valves, during procedures on 3 different occasions when the valve knob has been turned off, there would be continuous dripping into the waste bag."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910669 ↗
• MalfunctionSep 24, 2026Fluid/Blood Leak

  It was reported that "We have experienced leaking valves, during procedures on 3 different occasions when the valve knob has been turned off, there would be continuous dripping into the waste bag."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888789 ↗
• MalfunctionSep 23, 2026Fluid/Blood Leak

  It was reported that "We have experienced leaking valves, during procedures on 3 different occasions when the valve knob has been turned off, there would be continuous dripping into the waste bag."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868839 ↗