ICU Medical MC330623Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709097667), received between Apr 1, 2025 and Sep 15, 2026 — classified as 3 malfunctions.

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

8 other recalls cover devices cleared under the same FDA submission (K100576); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777905 ↗
• MalfunctionMay 23, 2026Fluid/Blood Leak

  COMPLAINT EMAIL FROM (B)(6), SUPERVISOR OF (B)(6) HOSPITAL WAS RECEIVED WITH REGARDS TO A 9" (23 CM) APPX 0.67 ML, EXT SET PRESSURE INFUSION (400 PSIG) W/2 MICROCLAVE CLEAR, PURPLE CLAMP, ROTATING LUER WHERE THE REPORTER STATED THAT THE PATIENT WENT TO CT SCAN AND WHEN THEY CAME BACK, THE IV TUBING-RUBBER PLUG INSIDE THE MICROCLAVE HAD PROLAPSED OUTSIDE OF THE PLASTIC MICROCLAVE. THE EVENT OCCURRED IN EMERGENCY DEPT. AT (B)(6). THERE WAS PATIENT INVOLVEMENT BUT UNKNOWN ADVERSE EVENT. UNSURE OF HOW THIS OCCURRED. THERE WERE NO ADVERSE EVENT AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25266291 ↗
• MalfunctionApr 1, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A 9" (23 CM) APPX 0.67 ML, EXT SET PRESSURE INFUSION (400 PSIG) W/2 MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT DURING THE INTRAVENOUS (IV) CONTRAST INJECTION, THE CONTRAST FLOWED THROUGH THE CLAMP OFF SECOND LUMEN OUT ONTO THE PATIENT. THE VALVE BROKE AND THE RUBBER/SILICON PIECE STICKING OUTSIDE OF HUB. THE PURPLE CLAMP WAS CLOSED. THE INJECTION OF CONTRAST WAS GOING INTO THE UNCLAMPED LUMEN. THE PRESSURE CAUSED THE CONTRAST TO FLOW UP THROUGH THE OTHER CLAMPED OFF LUMEN AND FORCED THE RUBBER VALVE TO POP OUT OF IV. THE CONTRAST/LIQUID THEN FLOWED ALL OVER THE PATIENT INTO THE COMPUTED TOMOGRAPHY (CT) TABLE. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21742812 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100576. 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
• Z-1720-2022 · Aug 1, 2022 · Open, Classified
  8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
• Z-0197-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring), Rotating Luer; unit per pouch, 50 multi
• Z-0201-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case.
• Z-0204-2021 · Jul 6, 2020 · Terminated
  6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per
• Z-0193-2021 · Jul 6, 2020 · Terminated
  6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purple Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouche
• Z-0192-2021 · Jul 6, 2020 · Terminated
  9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connector, 3 Purple Clamps, Rotating Luer. 1 unit per pouch, 50 mul
• Z-1916-2020 · Oct 4, 2019 · Terminated
  REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00887709026889