ICU Medical SF3258-15H-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887709120201), received between Aug 22, 2025 and Oct 17, 2025 — classified as 5 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K142367); they may or may not involve this specific model.

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

• MalfunctionOct 17, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  THE EVENT INVOLVED A SECONDARY SET 34 INCH WITH IV SET HANGER, SECURE LOCK WHERE IT WAS REPORTED THAT ZOFRAN INFUSION WAS LEAKING. INFUSION STOPPED SECONDARY IV SET NOTED TO HAVE A HOLE IN THE TUBING. THE LEAK OCCURRED ON AN IV PUMP AND WAS CLEANED PER HOSPITAL PROTOCOL. THERE WAS NO PATIENT HARM BUT THERE WAS SLIGHT DELAY IN THERAPY WHILE SWITCHING OUT THE SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328008 ↗
• MalfunctionOct 15, 2025No Flow; No Flow

  THE EVENT INVOLVED SECONDARY SET 34 INCH WITH IV SET HANGER, SECURE LOCK WHERE IT WAS REPORTED THAT CHEMO WOULD NOT FLOW OUT OF THE SECONDARY SET WHILE USING THE BD ALARIS PUMP AND SET. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM BUT THERE WAS A DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290790 ↗
• MalfunctionOct 15, 2025No Flow; No Flow

  THE EVENT INVOLVED A SECONDARY SET 34 INCH WITH IV SET HANGER, SECURE LOCK WHERE IT WAS REPORTED THAT CHEMO WOULD NOT FLOW OUT OF THE SECONDARY SET WHILE USING THE BD ALARIS PUMP AND SET. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM BUT THERE WAS A DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289542 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A SECONDARY SET 34 INCH WITH IV SET HANGER, SECURE LOCK. IT WAS REPORTED THAT THE SECONDARY LINE FOR ZOMETA WHICH IS A CLASS R MEDICATION RUNNING AS A SECONDARY, STARTED LEAKING. THIS IS A MAJOR SAFETY ISSUE POTENTIALLY EXPOSING TEAM MEMBER AND PATIENT TO MEDICATION. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS WHEN THE DEVICE WAS OPENED AND CONNECTED TO MEDICATION. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285756 ↗
• MalfunctionAug 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877724 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142367. One submission often covers many models, so check the product and lot details in each record.

• Z-3160-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers