ICU Medical A1129Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00887709068193), received between Jan 20, 2025 and Sep 9, 2025 — classified as 1 death, 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Material Separation; Material Separation

  THE EVENT INVOLVED A 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 WHERE IT WAS REPORTED THAT THE TUBING BROKE OFF RIGHT AT THE T-CONNECT PART. NO REPORTED PATIENT INVOLVEMENT OR HARM. THIS REPORT CAPTURES 2 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23008972 ↗
• MalfunctionJun 3, 2025Leak/Splash; Obstruction of Flow; Leak/Splash; Obstruction of Flow

  THE COMPLAINT/EVENT INVOLVED A 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. AT 12:53PM, BECAUSE THE INFUSION PUMP ALARMED FOR 'DOWNSTREAM OCCLUSION', THE INFUSION WAS STOPPED. THE MAIN LINE WAS CHECKED FOR KINKS AND THERE WERE NONE. THE LINE WAS DISCONNECTED FROM T-CONNECTOR, TO FLUSH THE IV IN RIGHT AC (AN INTRAVENOUS LINE IN THE RIGHT ANTECUBITAL FOSSA), AND MEDICATION (RENFLEXIS) SPRAYED THE NURSE'S LEFT FOREARM, THE PATIENT'S GLASSES AND SHIRT AS IF THERE WAS BACKFLOW. UPON FLUSHING THE IV, THE PATIENT STATED THAT HE FELT PAIN AND THE NURSE NOT ABLE TO GET BLOOD RETURN. THE IV WAS DISCONTINUED, NO SWELLING OR REDNESS NOTED, AND WARM PACKS WERE APPLIED. A NEW IV WAS PLACED, VIA US (ULTRASOUND GUIDANCE), IN LEFT FOREARM.

  Patient problems: Pain

  MAUDE report 22132213 ↗
• MalfunctionMay 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 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 WHERE THE CUSTOMER REPORTED THAT THE IV CONNECTOR BLEW OUT THE OTHER SIDE WHILE CLAMPED AND LEAKED (NON CHEMO), DURING PATIENT USE/FLUID FLUSH. PATIENT STATUS WAS HEALTHY BEFORE, DURING, AFTER REPORTED ISSUE. THERE WAS A DELAY IN THERAPY BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972937 ↗
• MalfunctionMay 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18 CM) SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP, NANOCLAVE® T-CONNECTOR (PURPLE RING), ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE CONNECTOR EXTENSION LEAKED NORMAL SALINE (BAXTER) WHEN ATTEMPTING TO FLUSH IV LINE. ADDITIONALLY, UPON CONNECTION TO CLOSER T PORTION INTO THE CONNECTOR, IT WOULD STILL LEAK AS SIDE PORTION. THE EVENT OCCURRED DURING UV FLUSH. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962613 ↗
• DeathMar 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED STATING 2 T-CONNECTORS STARTED LEAKING WITH ADMINISTRATION OF RAPID BLOOD ADMINISTRATION, AND T-CONNECTOR STARTED LEAKING WITH ADMINISTRATION OF FLUSH.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21702096 ↗
• MalfunctionFeb 7, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A 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 THAT EXPERIENCED BREAKAGE AND LEAKAGE. IT WAS STATED IN THE REPORT THAT ONCE OF MY CUSTOMERS IS EXPERIENCING LEAKING AND INJECTION PORTS ARE BREAKING; DR. STATED THAT THE T-CONNECTOR THE PATIENT CAME WITH FROM THE CICU WAS BROKEN. THE REPLACEMENT ALSO BROKE, THIS TIME IT¿S THE INJECTION PORT CLOSEST TO THE HUB CONNECTED TO THE PIV THAT BROKE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT WERE HARMED BUT THERE WAS A DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21335004 ↗
• MalfunctionFeb 7, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A 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 THAT EXPERIENCED BREAKAGE AND LEAKAGE. THIS IS REPORT 2 OF 2. IT WAS STATED IN THE REPORT THAT ONCE OF MY CUSTOMERS IS EXPERIENCING LEAKING AND INJECTION PORTS ARE BREAKING; DR. STATED THAT THE T-CONNECTOR THE PATIENT CAME WITH FROM THE CICU WAS BROKEN. THE REPLACEMENT ALSO BROKE, THIS TIME IT¿S THE INJECTION PORT CLOSEST TO THE HUB CONNECTED TO THE PIV THAT BROKE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT WERE HARMED BUT THERE WAS A DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334718 ↗
• MalfunctionFeb 7, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A 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 THAT EXPERIENCED BREAKAGE AND LEAKAGE. THIS IS REPORT 1 OF 2. IT WAS STATED IN THE REPORT THAT ONCE OF MY CUSTOMERS IS EXPERIENCING LEAKING AND INJECTION PORTS ARE BREAKING; DR. STATED THAT THE T-CONNECTOR THE PATIENT CAME WITH FROM THE CICU WAS BROKEN. THE REPLACEMENT ALSO BROKE, THIS TIME IT¿S THE INJECTION PORT CLOSEST TO THE HUB CONNECTED TO THE PIV THAT BROKE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT WERE HARMED BUT THERE WAS A DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334652 ↗
• MalfunctionJan 20, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 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. LEAKAGE OF AN UNSPECIFIED INFUSATE WAS REPORTED WITH THE T-CONNECTOR (WHERE THE MALE ADAPTER CONNECTS) WHILE HAND FLUSHING IN THE EMERGENCY DEPARTMENT. THERE WAS NO REPORT OF HUMAN HARM. A SECOND DEVICE WAS RETURNED FOR EVALUATION, CONFIRMING A CRACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21193280 ↗

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-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-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-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