ICU Medical MC33371Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00887709038172), received between Aug 7, 2024 and May 21, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Fluid/Blood Leak

  EMAIL COMPLAINT FROM LAUREN SALINAS OF TEXAS CHILDREN¿S HOSPITAL WAS RECEIVED WITH REGARDS TO A 4.5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, LUER LOCK. THE REPORTER STATED THAT THE DEVICE WAS BROKEN AND LEAKING. THERE WAS PATIENT INVOLVEMENT BUT NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25244621 ↗
• MalfunctionMay 21, 2026Fluid/Blood Leak

  EMAIL COMPLAINT FROM LAUREN SALINAS OF TEXAS CHILDREN¿S HOSPITAL WAS RECEIVED WITH REGARDS TO A 4.5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, LUER LOCK. THE REPORTER STATED THAT THE DEVICE WAS BROKEN AND LEAKING. THERE WAS PATIENT INVOLVEMENT BUT NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25244615 ↗
• MalfunctionSep 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED REGARDING A 4.5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE CLEAR, 2 CLAMPS, LUER LOCK WHERE IT WAS REPORTED THAT THE PATIENTS PJ'S WAS FOUND COVERED IN BLOOD AND THEY FOUND THE SOURCE OF BLEEDING WAS LEAKING FROM THE BIFUSE CONNECTED TO HER PERIPHERALLY INSERTED CENTRAL CATHETER LINE (PICC). THEY IMMEDIATELY CLAMPED BOTH LUMENS. THE BIFUSE APPEARED TO HAVE BEEN KINKED AND THEN SNAPPED. THEN THEY CHANGED OUT BOTH BIFUSES AND DIDN'T HAVE ANY FURTHER ISSUES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23102619 ↗
• MalfunctionAug 13, 2025Break; Break

  A COMPLAINT WAS RECEIVED REGARDING A 4.5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, LUER LOCK THAT EXPERIENCED BREAKAGE DURING USE. THE REPORT STATED, "NURSE NOTICED BROKEN BIFUSE IN THE PATIENT'S HIGHCHAIR".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795772 ↗
• MalfunctionAug 12, 2025Disconnection; Disconnection

  A COMPLAINT WAS RECEIVED REGARDING A 4.5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, LUER LOCK THAT EXPERIENCED DISCONNECTION. THE REPORT STATED "MC DISCONNECTION". THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22788932 ↗
• MalfunctionAug 12, 2025Material Separation; Material Separation

  EVENT OCCURRED ON AN UNSPECIFIED DATE REGARDING A 4.5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, LUER LOCK WHERE THEY REPORTED BROKEN BIFUSE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22787605 ↗
• MalfunctionAug 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN EVENT WAS REPORTED THAT OCCURRED BETWEEN (B)(6) 2025 TO (B)(6) 2025. THE REPORTER STATED THAT A 4.5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, LUER LOCK WAS 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 22716147 ↗
• 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 4.5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, LUER LOCK WAS BROKEN AND LEAKING AN UNSPECIFIED FLUID/INFUSATE DURING PATIENT USE. THERE WAS NO REPORT OF ANY HUMAN HARM. THERE WERE 3 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 22716014 ↗
• MalfunctionJul 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 4.5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, LUER LOCK WHERE THE CUSTOMER REPORTED THAT THE NURSE USED A BIFURCATION THAT WAS ATTACHED TO THE PATIENTS IV. BOTH LINES GOING TO THE BIFURCATION WERE RUNNING NORMAL SALINE. AFTER THE FLUID WAS RUNNING FOR A COUPLE OF MINUTES, THE PATIENT NOTICED THERE WAS WATER DRIPPING OUT. THE CUSTOMER CHECKED BOTH LINES THINKING THEY HAD NOT TIGHTENED THE LINES ONTO THE PORT VERY WELL BUT THEY WERE IN THEIR TIGHT. THE CUSTOMER STATED THAT BOTH PORTS WERE LEAKING / DRIPPING WATER; THEY CHANGED OUT THE BIFURCATION, MADE SURE THE NEW ONE DIDN'T LEAK. 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 22646132 ↗
• MalfunctionJun 27, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A 4.5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, LUER LOCK WHERE IT WAS REPORTED THAT THE BIFUSE WAS CRACKED AND LEAKING INTO ISOLETTE. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22351077 ↗
• MalfunctionDec 26, 2024Separation Problem; Separation Problem

  A COMPLAINT WAS RECEIVED WITH REGARDS TO REGARDS TO A 4.5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, LUER LOCK, THAT EXPERIENCED DISCONNECTION. IT WAS REPORTED THAT THE 4.5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, LUER LOCK HAD A SEPERATION ISSUE. IT WAS STATED THAT WHEN CHECKING PICC LINES BEFORE ADMINISTERING A MEDICATION, AND ONE OF THE CLAVES CONNECTED TO THE BIFUSE POPPED OFF. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21023965 ↗
• MalfunctionOct 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A SET EXTENSION 15IN 1.2UM FILTER 4.8PV CONTENT STRL ME1225 WAS FOUND TO HAVE DISCONNECTED DURING PATIENT USE IN UNIT 3 SW. THE REPORT STATED THAT THE PATIENT'S BIFUSE, WHICH WAS INFUSING MEDICATIONS THROUGH THEIR PERIPHERALLY INSERTED CENTRAL CATHETER (PICC), POPPED OFF. THE TUBING DISCONNECTED FROM THE PORT THAT WAS ATTACHED TO THE CLAVE. A SAMPLE PHOTO WAS PROVIDED SHOWING THE TUBES WERE POPPED OFF FROM THE CLAVE. THERE WAS PATIENT INVOLVEMENT AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20478067 ↗
• MalfunctionAug 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 4.5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, LUER LOCK WHERE THE CUSTOMER REPORTED THAT AT AROUND 2000 THE ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) THE REGISTERED NURSE NOTICED BLOOD DRIPPING DOWN THE PATIENT'S BED. UPON FURTHER INSPECTION IT WAS FOUND THAT THE SMALLBORE BIFUSE CONNECTED TO THE RIGHT INTERNAL JUGULAR VEIN CENTRAL VENOUS ACCESS (IJ CVL) HAD BROKEN AND BLOOD WAS DRIPPING FROM THE IJ INTO THE BED. THE BROKEN BIFUSE WAS IMMEDIATELY CLAMPED AND WHEN NEW SUPPLIES WERE GATHERED IT WAS REMOVED FROM THE PATIENT. THERE WAS A PATIENT INVOLVEMENT AND NO HARM OR ADVERSE EVENT REPORTED AS A CONSEQUENCE OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19933589 ↗

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-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-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-0236-2021 · Jul 6, 2020 · Terminated
  7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067582(17)241201(30)50(10)4548270; (01)1088770906
• Z-0234-2021 · Jul 6, 2020 · Terminated
  47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroClave Clear. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709121154(17)250101(30)25(10)4556714; (01
• Z-0202-2021 · Jul 6, 2020 · Terminated
  8" (20 cm) Appx 0.53 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(
• 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-0243-2021 · Jul 6, 2020 · Terminated
  78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD, FILTER .1 unit per pouch, 50 pouches per case. UDI:(01)10887709121703(17)250201(30)50(10)4723226.
• Z-0246-2021 · Jul 6, 2020 · Terminated
  40 (102cm) Appx 4.4ml Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps, Rotating Luer, 1 Ext. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709014531(17)250101(30)50
• Z-0255-2021 · Jul 6, 2020 · Terminated
  148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock.1 unit per pouch, 25 pouches per case. UDI:(01)10887709071558(17)250101(30)25(10)4603841. The Intrav

…and 173 more.