ICU Medical AM3127Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00887709122949), received between Apr 4, 2025 and Aug 5, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN EVENT WAS REPORTED THAT OCCURRED BETWEEN 02-JUL-2025 TO 04-JUL-2025. THE REPORTER STATED THAT A 11" (28 CM) APPX 1.1ML, SMALLBORE EXT SET W/3-PORT NANOCLAVE¿ MANIFOLD, CHECK VALVE, CLAVE¿ CLEAR, LUER LOCK WAS BROKEN AND LEAKING AN UNSPECIFIED FLUID/INFUSATE DURING PATIENT USE. THERE WAS NO REPORT OF ANY HUMAN HARM. THERE WERE 2 OCCURRENCES OF THE SAME ISSUE/FAILURE MODE WITH THE SAME LIST AND LOT NUMBER OF THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22717781 ↗
• MalfunctionJun 25, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE EVENT INVOLVED A 11" (28 CM) APPX 1.1 ML, SMALLBORE EXT SET W/3-PORT NANOCLAVE¿ MANIFOLD, CHECK VALVE, CLAVE¿ CLEAR, LUER LOCK WHERE IT WAS REPORTED THAT A PORT POPPED OFF OF THE MANIFOLD. THIS WAS ATTACHED TO AN UMBILICAL VENOUS CATHETER (UVC) AND WITH THIS PORT OPENED IT CREATED A BACKFLOW OF BLOOD INTO THE TUBING AND INTO THE PATIENT¿S BED. THERE WERE SURE HOW MANY CC'S OF BLOOD THE PATIENT LOST BUT LUCKILY IT WAS CAUGHT RELATIVELY SOON BY THE BEDSIDE RN. TO THE BEDSIDE RNS KNOWLEDGE, THERE WAS NOTHING MANIPULATED THE PORT FOR IT TO POP OFF. THE PRODUCT WAS USED DURING USE ON THE PATIENT. NEWLY PLACED LINE, MEDICATION HAD NOT YET RUN THROUGH IT. THE MEDICATION USED WAS 5% DEXTROSE IN WATER (D5%) FROM BAXTER. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM BUT LOST BLOOD AND LUCKILY IT WAS NOTICED QUICKLY. THERE WAS DELAY IN THERAPY SINCE PATIENT LOST UVC ACCESS AND HAD TO OBTAIN ADDITIONAL ACCESS DUE TO THIS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22332672 ↗
• MalfunctionJun 13, 2025Break; Break

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 11" (28 CM) APPX 1.1ML, SMALLBORE EXT SET W/3-PORT NANOCLAVE¿ MANIFOLD, CHECK VALVE, CLAVE¿ CLEAR, LUER LOCK WHERE IT WAS REPORTED THAT THE PATIENT HAD DOUBLE LUMEN UMBILICAL VENOUS CATHETER (UVC), BOTH WITH NEW MANIFOLDS RECENTLY PLACED IN EACH LUMEN ATTACHED TO MRI IV TUBING. ONE LUMEN ONLY HAD A CARRIER FLUID GOING WITH A MEDICATION LINE (NOT BEING USED AT THE TIME). AS THE PATIENT WAS IN MRI, THE LINES WERE THREADED TO THE WALL (AS STANDARD PROCEDURE). AS THEY WERE THREADED, THE ENTIRE PORT WITH THE MEDICATION LINE BROKE OFF, LEAVING THE MANIFOLD OPEN TO AIR, AS WELL AS THE UVC LUMEN. THE MANIFOLD WAS TAKEN OFF THE LUMEN AND THE IV FLUID CARRIER WAS ATTACHED DIRECTLY TO THE LUMEN ON THE UVC TO KEEP IT OPEN. THERE WAS PATIENT INVOLVEMENT, UNKNOWN HUMAN HARM. THIS REPORT CAPTURES 2 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203118 ↗
• MalfunctionJun 13, 2025Break; Break

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 11" (28 CM) APPX 1.1ML, SMALLBORE EXT SET W/3-PORT NANOCLAVE¿ MANIFOLD, CHECK VALVE, CLAVE¿ CLEAR, LUER LOCK WHERE IT WAS REPORTED THAT THE DEVICE WAS FOUND BROKEN IN BABY'S BED. NOT TIGHTENED. THERE WAS PATIENT INVOLVEMENT, UNKNOWN HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202985 ↗
• MalfunctionMay 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 11" (28 CM) APPX 1.1ML, SMALLBORE EXT SET W/3-PORT NANOCLAVE¿ MANIFOLD, CHECK VALVE, CLAVE¿ CLEAR, LUER LOCK WHERE IT WAS REPORTED THE MANIFOLD LEAKED. THE EVENT DATE OCCURRED OVER 19-APR-2025 AND 20-APR-2025. STATUS WAS DURING USE ON THE PATIENT. THERE WAS PATIENT INVOLVEMENT BUT NO HUMAN HARM. HOWEVER, THERE WAS A DELAY IN THERAPY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057283 ↗
• MalfunctionMay 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 11" (28 CM) APPX 1.1ML, SMALLBORE EXT SET W/3-PORT NANOCLAVE¿ MANIFOLD, CHECK VALVE, CLAVE¿ CLEAR, CLAMP, LUER LOCK. THE CUSTOMER REPORTED THAT THE PATIENT HAD A PERIPHERAL INTRAVENOUS LINE (PIV) AND SMOC LIPIDS INFUSING WHEN THE NURSE NOTICED THE PATIENT¿S LINENS WERE SOAKED. THE LEAK APPEARED TO COME FROM THE COLLAR AND EXTENSION BOND OF THE SET. WHEN THEY CHANGED AND RAN A SINGLE LINE, THEY NOTICED THERE WAS NO LEAKING. IT WAS IN USE THROUGHOUT THE NIGHT AFTER HANGING FLUIDS THE DAY BEFORE. THEY WENT BACK TO INFUSING THROUGH THE MANIFOLD AND THEN NOTICED THE LEAKING. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT AND THERE WAS DELAY IN THERAPY. THERE WERE 4 INSTANCES REPORTED ON UNSPECIFIED DATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21978285 ↗
• MalfunctionApr 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A 11" (28 CM) APPX 1.1ML, SMALLBORE EXT SET W/3-PORT NANOCLAVE¿ MANIFOLD, CHECK VALVE, CLAVE¿ CLEAR, LUER LOCK THAT EXPERIENCED LEAKAGE. THE REPORTER STATED THAT THEY HAD ENCOUNTERED LEAKING FROM THE EXACT SPOT OF WHERE THE COLLAR BONDS ONTO THE EXTENSION SET OF THE SET WHILE THEY WERE INFUSING LIPIDS. IT WAS ALSO STATED THAT THE ONLY DIFFERENCE WAS THEY WERE UNABLE TO SPIN THE COLLAR AND IT WAS JUST LEAKING. IT WAS ALSO STATED THAT IT WAS USED THROUGHOUT THE NIGHT AFTER HANGING FLUIDS. THE EVENT DATE OCCURRED ON (B)(6) 2025 DURING INFUSION. SAMPLE PHOTO WAS PROVIDED SHOWING THE DEFECTIVE PRODUCT THAT LEAKED. THUS, THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM AND THERE WAS DELAY IN THERAPY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922534 ↗
• MalfunctionApr 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING REGARDS TO A 11" (28 CM) APPX 1.1ML, SMALLBORE EXT SET W/3-PORT NANOCLAVE¿ MANIFOLD, CHECK VALVE, CLAVE¿ CLEAR, CLAMP, LUER LOCK THAT EXPERIENCED LEAKAGE. THE REPORTER STATED THAT THE LEAKING CAME FROM ITEM: AM3127 RIGHT WHERE THE MANIFOLD COLLARS TO THE EXTENSION SET WHICH IS SUPPOSED TO BE BONDED. THE COLLAR SPINS FREELY IN A 360 DEGREE TURN WHERE WHEN SPINNING IT., THE EXTENSION TUBING MOVES WITH IT. THEY PULL ANOTHER ITEM FROM INVENTORY TO TRY BUT WAS UNABLE TO SPIN THE COLLAR. THE PACKAGING WAS DISCARDED. THE PRODUCT IS FILLED WITH LIPIDS. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS DURING USE ON THE PATIENT. THE DEVICE WAS USED ANYWHERE FROM 4-7PM TO 7-8AM. SOMEONE BECAME AWARE WHEN THE LIPIDS WHERE LEAKING FROM THAT COLLAR ALL OVER THE PATIENT'S BED WHEN THE CLINICIAN CHECKED ON THE PATIENT. THE MEDICATION INVOLVED WAS SMOC (LIPIDS). THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT AND THERE WAS DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774344 ↗

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-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-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-0229-2021 · Jul 6, 2020 · Terminated
  78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV, MicroClave. 1 unit per pouch, 24 pouches per case.UDI:(01)10887709090634(17)241201(30)25(10)4537328. The I
• 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
• Z-0185-2021 · Jul 6, 2020 · Terminated
  5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouches per case; UDI: (01)10887709052809(17)250101(30)50(10)4599980.
• Z-0244-2021 · Jul 6, 2020 · Terminated
  128" (325 cm) Appx 16.6 ml, 15 Drop Primary Set w/2 MicroClave, Remv 2 Gang 4-Way Clave Stopcock, Rotating Luer, 2 Ext. 1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887
• Z-0206-2021 · Jul 6, 2020 · Terminated
  60" (152 cm) Appx 1.0 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave, 0.2 Micron Filter, 1.2 Micron Filter, 4 Clamps (2 Blue, Yellow, White), Rotating Luer; 1 unit p
• Z-0231-2021 · Jul 6, 2020 · Terminated
  10 IN (25cm) APPX 1.5ml, Ext w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709080796(17)241201(30)50(10)4536743; (01)1088770908
• 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

…and 173 more.