ICU Medical MC33327Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709037762), received between Oct 24, 2024 and Apr 24, 2025 — 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.

• MalfunctionApr 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A MEDSUN/MEDWATCH REPORT #MW5167729 RECEIVED ON 27-MAR-2025 STATING THAT WHILE STARTING AN IV, THE J-LOOP WAS LEAKING AN UNSPECIFIED FLUID. ALL PIECES WERE ATTACHED APPROPRIATELY, AND NO CRACKS NOTED. ADDITIONAL EVENT INFORMATION OBTAINED FROM THE USER FACILITY MEDWATCH (UFMW) FORM: INITIAL REPORTER ASKED TO REMAIN CONFIDENTIAL. THE SUSPECT MEDICAL DEVICE IS 7" (18CM) APPX 0.41 ML, PRESSURE INFUSION (400PSIG) EXT SET W REMV MICROCLAVE CLEAR, PURPLE CLAMP, LUER LOCK. THE MEDWATCH REPORT INDICATES THAT AN UNSPECIFIED INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21899708 ↗
• MalfunctionJan 2, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE COMPLAINT WAS RECEIVED VIA MEDWATCH MDR REPORT # MW5162367 (ATTACHED) AND INVOLVED A 7" (18 CM) APPX 0.41 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE¿ CLEAR, PURPLE CLAMP, LUER LOCK. THE REPORT STATED: "BILATERAL IV SITES WENT BAD DURING OPERATING ROOM CASE. DR. IDENTIFIED THIS AS AN ISSUE WITH THE EXTENSION TUBING AND ITS CONNECTION TO THE IV HUB COMING UNDONE CAUSING THE IV TO "BLOW". STAFF HAS NOTED THAT THE 7" (18CM) APPX 0.41 PRESSURE INFUSION EXTENSION SET MAY BE COMING UNDONE WITH MINIMAL MANIPULATION OF THE IV LINE DUE TO HOW THICK THE IV EXTENSION SET IS, CAUSING IT TO ROTATE AT THE HUB CONNECTION RESULTING IN LEAKING OR UNINTENDED DISCONNECTIONS. THIS RESULTED IN THE PATIENT MOVING DURING THE SURGERY AND EMERGENT NEED FOR ADDITIONAL IV ACCESS INTRAOPERATIVELY." THERE WAS PATIENT INVOLVEMENT, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21056744 ↗
• MalfunctionOct 24, 2024Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 7" (18 CM) APPX 0.46 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK WHERE IT WAS REPORTED THE SET WAS LEAKING. THE LEAK OCCURRED AT THE CONNECTION FROM THE EXTENSION SET LEUR TO THE CATHETER END EXTERNALLY FROM THE PATIENT. NO HOLE, CUT, TEARS NOTED, THE SITE BECOMES LOOSE AT THE CONNECTION SITE EITHER DURING THE INFUSION OR AT THE END OF THE INFUSIONS. NO BLOOD LOSS OR BLEED BACK. THE MEDICATION THAT LEAKED WAS CHEMOTHERAPY WITH FLUIDS. THERE WAS PATIENT INVOLVEMENT AND NO HARM, BUT PATIENTS AND STAFF ARE BEING EXPOSED TO CHEMO LEAKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522644 ↗

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-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-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-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-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-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