ICU Medical AM6109Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00887709077645), received between May 2, 2023 and Dec 4, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 reports).

188 other recalls cover devices cleared under the same FDA submission (K964435); 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 10" (25 CM) SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER AND IT WAS REPORTED THAT THE PRODUCT IS LEAKING WHICH CAUSED ISSUES FOR THEIR PATIENTS. THEY OBSERVED LEAKAGE IN TWO SEPARATE PATIENTS AT THE CONNECTION POINT TO THE PATIENT'S LINE, POST WHITE CLAMP. THE EVENT OCCURRED DURING INFUSION AND PATIENT LOSS OF CRITICAL FLUIDS AND DROP IN GLUCOSE. THERE WERE PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED. THIS REPORT CAPTURES THE SECOND OF TWO INCIDENTS.

  Patient problems: Hypoglycemia

  MAUDE report 23723860 ↗
• InjuryDec 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION STATING THE GLUCOSE DROPPED LOW (<20) REQUIRING BOLUSES OF DEXTROSE IN ONE OF THE PATIENTS. THIS REPORT CAPTURES THE PATIENT THAT REQUIRED INTERVENTION.

  Patient problems: Hypoglycemia

  MAUDE report 23723853 ↗
• MalfunctionAug 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE MANIFOLD OF A '10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER' WAS REPORTEDLY BEGAN LEAKING AN UNSPECIFIED FLUID/MEDICATION DURING A PATIENT'S INFUSION. THE CUSTOMER STATED THAT A CHEMO SPILL KIT WAS NOT NEEDED. THERE WAS NO INJURY TO THE PATIENT AND NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840561 ↗
• MalfunctionOct 31, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A 10" (25 CM) SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER WAS FOUND TO HAVE LEAKED DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT THEY UTILIZED SIX PORT MANIFOLDS FOR CONTINUOUS INTRAVENOUS (IV) INFUSIONS ON PATIENTS. MANIFOLD RUNNING WITH MULTIPLE INOTROPES TO SUPPORT THE PATIENT'S HEMODYNAMICS. BEDSIDE THEY WERE REVIEWING LINES AND NOTED THE BED TO BE WET WHERE THE MANIFOLD WAS LAYING. WHEN THE MANIFOLD WAS INSPECTED, ONE OF THE PORTS WAS COMPLETELY BROKEN OFF AND LYING IN THE BED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578654 ↗
• MalfunctionOct 31, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A 10" (25 CM) SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER WAS FOUND TO LEAK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT THEY FOUND A WET SPOT ON THE BED UNDER THE MANIFOLD OF THE PATIENT, MEDICATIONS GOING INTO THE MANIFOLD INCLUDED EPI FOR BP MANAGEMENT AND DEX FOR SEDATION. FOUND TO HAVE A LEAK/CRACK IN MANIFOLD-TAIL CONNECTION ALL ONE PIECE IN THE PACKAGE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578454 ↗
• MalfunctionOct 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 10" (25 CM) SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER WAS FOUND TO GENERATE A LEAK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT THE PATIENT LINE WAS WORKING APPROPRIATELY THROUGH THE SHIFT. AT 0600 THEY NOTICED IT WAS WET AT THE MANIFOLD, SEEN DRIPPING AT THE CONNECTION NEAREST TO THE PATIENT BETWEEN THE MANIFOLD AND CAP. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20575469 ↗
• MalfunctionOct 30, 2024Break; Break

  IT WAS REPORTED THAT A 10" (25 CM) SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER WAS FOUND TO HAVE BROKEN DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT THE PATIENT'S MANIFOLD MALFUNCTIONED. THE LUER LOCK AT THE "TAIL" OF THE MANIFOLD SEPARATED FROM THE BLUE CLAVE WITH A PORTION OF THE BLUE CLAVE BROKEN OFF WITHIN THE LUER LOCK. THE MANIFOLD COULD NOT BE REATTACHED. THIS EVENT RESULTED IN THE ABRUPT DISCONTINUATION OF SEVERAL CONTINUOUS MEDICATIONS BEING DELIVERED INTO THE PATIENT'S NEONATAL PERIPHERALLY INSERTED CENTRAL CATHETERS (NEOPICC). THE CRITICALLY ILL PATIENT WAS AT RISK OF CLOTTING THE NEOPICC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20575461 ↗
• InjuryOct 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  NEW INFORMATION WAS RECEIVED STATING THAT THE MEDICATION NOT REACHED THE PATIENT LEADING TO DETERIORATING VITAL SIGNS, INCREASED AGITATION. PATIENT RECOVERED AFTER BROKEN MANIFOLD REPLACED. THE DELAY IN THERAPY OCCURRED AFTER CAP CHANGE. THERE WAS PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20571387 ↗
• MalfunctionOct 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 25 CM (10") PUR YELLOW SMALLBORE EXT SET, 6-PORT NANOCLAVE¿ MANIFOLD W/CHECK VALVE, NANOCLAVE¿, 4-WAY NANOCLAVE¿ STOPCOCK (RED RING), ROTATING LUER. THE DEVICE REPORTEDLY LEAKED AT THE WELDS OF ONE OF THE STRANDS AND PARENTERAL NUTRITION SPILLED INTO BED DURING INFUSION. CLINICAL CONSEQUENCES NOTED: PARENTERAL NUTRITION WAS STOPPED, THE MEDICAL DEVICE WAS REPLACED AND A PEDIAVEN WAS SET UP, WHICH LED TO A DELAY IN THERAPY. THERE WERE REPORTED RISKS OF INFECTION AND GAS EMBOLISM. THERE WERE NO HOLES, CUTS, TEARS, AND NO VISIBLE SIGNS OF MALFUNCTION, DAMAGE, OR PROBLEMS WITH THE DEVICE PRIOR TO THE INCIDENT. THERE WAS NO BLOOD LOSS, THE LEAK DID NOT COME INTO CONTACT WITH THE PATIENT NOR THE HEALTHCARE PROVIDER. THE PATIENT WAS STABLE, THE HOSPITAL STAY WAS NOT EXTENDED, NO ONE WAS HARMED, AND ADDITIONAL MEDICAL INTERVENTION WAS NOT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396379 ↗
• MalfunctionAug 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE INCIDENT INVOLVED A 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER. IT WAS REPORTED THAT THERE WAS LEAKING FOUND IN THE PATIENT'S BED. THE LEAK LOCATION IS UNKNOWN. THE EVENT OCCURRED IN NEONATAL INTENSIVE CARE UNIT (NICU). THE REPORTER BECAME AWARE OF THE ISSUE WHEN THEY NOTICED THAT PATIENT'S SHEET WAS WET. THE MEDICATION INVOLVED IS UNKNOWN. THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THERE WAS PATIENT INVOLVEMENT, NO HARM/ADVERSE EVENT, AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17585254 ↗
• MalfunctionMay 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER WHICH WAS REPORTED TO HAVE LEAKED DURING PATIENT INFUSION ON AN INFANT. IT WAS REPORTED THAT DUE TO THE LEAKING TUBING, THE BABY HAD AN ACUTE BLOOD PRESSURE DROP DESPITE INCREASED DRIP RATE AND DOSING RETURNED TO INFANT'S BASELINE ONCE THE TUBING WAS REPLACED. THERE WAS A DELAY IN THERAPY FOR APPROXIMATELY 30 MINUTES OF INEFFECTIVE BLOOD PRESSURE DRIP/IV NUTRITION INFUSION. THERE WAS A CONTINUOUS INFUSION OF TOTAL PARENTERAL NUTRITION (TPN), FENTANYL, DOPAMINE, NOREPINEPHRINE, AND OMEGAVAN. THE MEDICATION CAME IN CONTACT WITH THE PATIENT. THE CUSTOMER ALSO NOTED TWISTING OF CONNECTION LOCK BETWEEN MANIFOLD AND MANIFOLD TUBING.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 16857085 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964435. One submission often covers many models, so check the product and lot details in each record.

• Z-3163-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-3157-2026 · May 12, 2026 · Open, Classified
  IV Non-Dedicated Gravity Administration Sets with drip chambers
• Z-0154-2026 · Oct 2, 2025 · Open, Classified
  IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B
• Z-1721-2022 · Aug 1, 2022 · Open, Classified
  6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
• Z-0955-2021 · Dec 2, 2020 · Terminated
  60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pr
• Z-0957-2021 · Dec 2, 2020 · Terminated
  7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pro
• Z-0958-2021 · Dec 2, 2020 · Terminated
  154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides ac
• Z-0956-2021 · Dec 2, 2020 · Terminated
  60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a singl
• Z-0215-2021 · Jul 6, 2020 · Terminated
  29 IN (74 cm) APPX 3.9 ml, EXT SET w/ NanoClave 4-Way Stopcock; 1 unit per pouch, 50 pouches per case. UDI:(01)10840619082533(17)250101(30)50(10)4605138. The Intravascular Admi
• Z-0230-2021 · Jul 6, 2020 · Terminated
  114" (290 cm) 60 Drop 150ml Burette Set (Clave, Shut Off, Filter) w/4 Clave Remv 3-Port NanoClave Manifold, 2 Check Valves, Rotating Luer, 2 Exts. 1 unit per pouch, 25 pouches per
• Z-0240-2021 · Jul 6, 2020 · Terminated
  11 IN(28cm)APPX 0.97ml,SMALLBORE SET,NanoClave,6-PORT NanoClave MANIFOLD,BCV.1 unit per pouch, 50 pouches per case. UDI:(01)10887709088354(17)250101(30)50(10)4557643. The Intrava
• Z-0183-2021 · Jul 6, 2020 · Terminated
  6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI:(01)10887709051024(17)250101(30)50(10)
• Z-0235-2021 · Jul 6, 2020 · Terminated
  10 IN (25cm) APPX 1.5ml EXT w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067322(17)250101(30)50(10)4565730; (01)10887709067322(
• Z-0254-2021 · Jul 6, 2020 · Terminated
  22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051967(17)250101(30)50(10)4605591; (01)10
• Z-0247-2021 · Jul 6, 2020 · Terminated
  7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(17)250101(30)50(10)4572133. The Intravasc

…and 173 more.