ICU Medical M9000-EFRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709078536), received between Nov 22, 2025 and Jul 15, 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 18, 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.

• MalfunctionJul 15, 2026Fluid/Blood Leak

  A REPORTED INCIDENT INVOLVED AN ENFIT LOPEZ VALVE, NON-STERILE THE REPLACEMENT THAT WAS SENT TO THE CUSTOMER WAS LEAKING. THERE WAS NO REPORTED PATIENT INVOLVEMENT WITH NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25832020 ↗
• MalfunctionJun 22, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A ENFIT LOPEZ VALVE, NON-STERILE WHICH WAS REPORTED THAT THE REPLACEMENT THAT WAS SENT TO THE CUSTOMER WAS LEAKING THIS IS THE SECOND COMPLAINT THE CUSTOMER HAD ON THIS ISSUE. THERE WAS NO REPORTED PATIENT INVOLVEMENT WITH NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25577222 ↗
• MalfunctionMar 31, 2026Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED AN ENFIT LOPEZ VALVE. IT WAS REPORTED THAT THE PIECE FITS BUT DOES NOT STAY IN THE G-TUBE. IT EASILY FALLS OUT AND CAUSES LEAKS. WE WERE HAVING TO EITHER TAPE THE PIECE BELOW TO THE G-TUBE OR USE THE 5-IN-1 CONNECTOR TO TRY TO KEEP THE TUBE FEEDING CONNECTED TO THE G-TUBE. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24739325 ↗
• MalfunctionNov 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A ENFIT¿ LOPEZ VALVE, NON-STERILE. AN EMAIL WAS RECEIVED REGARDING A ENFIT LOPEZ VALVE, NON-STERILE WITH LIST NUMBER M9000-EF AND UNKNOWN LOT NUMBER. IT WAS STATED THAT VALVE IS LEAKING. SAMPLE IS NOT AVAILABLE FOR EVALUATION. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23625707 ↗