ICU Medical MC33722Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00887709064942), received between Feb 7, 2025 and Mar 26, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7.5" TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 4 CLAMPS (2 WHITE, BLUE, RED), LUER LOCK WHERE THE CUSTOMER REPORTED THAT THEY HAVE HAD MANY INCIDENTS OF TRIFUSE BREAKING OFF FROM THE LUER CONNECTION. ALL THE BREAKS HAPPENED WHERE THE MALE LUER LOCK INSERTS INTO THE PATIENT¿S MICROCLAVE CAP. THIS RESULTED IN BLOOD LOSS AND IVF LOSS FOR THE PATIENTS, CHEMO SPILLS, AND CAN POTENTIALLY CAUSE HARM FOR THE PATIENTS, HOWEVER, SPECIFIC INFORMATION REGARDING VOLUME OF BLOOD LOSS WAS NOT AVAILABLE BUT THE CUSTOMER DID STATE THAT THE MAJORITY OF THE BLOOD LOSS WAS NOT SUBSTANTIAL ENOUGH TO REQUIRE BLOOD TRANSFUSION. THERE MAY HAVE BEEN SOME CHEMO EXPOSURE, BUT NONE REQUIRED EMERGENT CARE OR TREATMENT. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THEY ARE UNABLE TO GIVE ACCURATE INFORMATION ABOUT WHICH BROKEN EXTENSION TUBING (BI/TRI/QUAD FUSE) HAD HARM. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702484 ↗
• MalfunctionMar 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7.5" TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 4 CLAMPS (2 WHITE, BLUE, RED), LUER LOCK WHERE THE CUSTOMER REPORTED THAT THEY HAVE HAD MANY INCIDENTS OF TRIFUSE BREAKING OFF FROM THE LUER CONNECTION. ALL THE BREAKS HAPPENED WHERE THE MALE LUER LOCK INSERTS INTO THE PATIENT¿S MICROCLAVE CAP. THIS RESULTED IN BLOOD LOSS AND IVF LOSS FOR THE PATIENTS, CHEMO SPILLS, AND CAN POTENTIALLY CAUSE HARM FOR THE PATIENTS, HOWEVER, SPECIFIC INFORMATION REGARDING VOLUME OF BLOOD LOSS WAS NOT AVAILABLE BUT THE CUSTOMER DID STATE THAT THE MAJORITY OF THE BLOOD LOSS WAS NOT SUBSTANTIAL ENOUGH TO REQUIRE BLOOD TRANSFUSION. THERE MAY HAVE BEEN SOME CHEMO EXPOSURE, BUT NONE REQUIRED EMERGENT CARE OR TREATMENT. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THEY ARE UNABLE TO GIVE ACCURATE INFORMATION ABOUT WHICH BROKEN EXTENSION TUBING (BI/TRI/QUAD FUSE) HAD HARM. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702473 ↗
• MalfunctionMar 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7.5" TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 4 CLAMPS (2 WHITE, BLUE, RED), LUER LOCK WHERE THE CUSTOMER REPORTED THAT THEY HAVE HAD MANY INCIDENTS OF TRIFUSE BREAKING OFF FROM THE LUER CONNECTION. ALL THE BREAKS HAPPENED WHERE THE MALE LUER LOCK INSERTS INTO THE PATIENT¿S MICROCLAVE CAP. THIS RESULTED IN BLOOD LOSS AND IVF LOSS FOR THE PATIENTS, CHEMO SPILLS, AND CAN POTENTIALLY CAUSE HARM FOR THE PATIENTS, HOWEVER, SPECIFIC INFORMATION REGARDING VOLUME OF BLOOD LOSS WAS NOT AVAILABLE BUT THE CUSTOMER DID STATE THAT THE MAJORITY OF THE BLOOD LOSS WAS NOT SUBSTANTIAL ENOUGH TO REQUIRE BLOOD TRANSFUSION. THERE MAY HAVE BEEN SOME CHEMO EXPOSURE, BUT NONE REQUIRED EMERGENT CARE OR TREATMENT. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THEY ARE UNABLE TO GIVE ACCURATE INFORMATION ABOUT WHICH BROKEN EXTENSION TUBING (BI/TRI/QUAD FUSE) HAD HARM. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702472 ↗
• MalfunctionMar 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7.5" TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 4 CLAMPS (2 WHITE, BLUE, RED), LUER LOCK WHERE THE CUSTOMER REPORTED THAT THEY HAVE HAD MANY INCIDENTS OF TRIFUSE BREAKING OFF FROM THE LUER CONNECTION. ALL THE BREAKS HAPPENED WHERE THE MALE LUER LOCK INSERTS INTO THE PATIENT¿S MICROCLAVE CAP. THIS RESULTED IN BLOOD LOSS AND IVF LOSS FOR THE PATIENTS, CHEMO SPILLS, AND CAN POTENTIALLY CAUSE HARM FOR THE PATIENTS, HOWEVER, SPECIFIC INFORMATION REGARDING VOLUME OF BLOOD LOSS WAS NOT AVAILABLE BUT THE CUSTOMER DID STATE THAT THE MAJORITY OF THE BLOOD LOSS WAS NOT SUBSTANTIAL ENOUGH TO REQUIRE BLOOD TRANSFUSION. THERE MAY HAVE BEEN SOME CHEMO EXPOSURE, BUT NONE REQUIRED EMERGENT CARE OR TREATMENT. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THEY ARE UNABLE TO GIVE ACCURATE INFORMATION ABOUT WHICH BROKEN EXTENSION TUBING (BI/TRI/QUAD FUSE) HAD HARM. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702463 ↗
• MalfunctionMar 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7.5" TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 4 CLAMPS (2 WHITE, BLUE, RED), LUER LOCK WHERE THE CUSTOMER REPORTED THAT THEY HAVE HAD MANY INCIDENTS OF TRIFUSE BREAKING OFF FROM THE LUER CONNECTION. ALL THE BREAKS HAPPENED WHERE THE MALE LUER LOCK INSERTS INTO THE PATIENT¿S MICROCLAVE CAP. THIS RESULTED IN BLOOD LOSS AND IVF LOSS FOR THE PATIENTS, CHEMO SPILLS, AND CAN POTENTIALLY CAUSE HARM FOR THE PATIENTS, HOWEVER, SPECIFIC INFORMATION REGARDING VOLUME OF BLOOD LOSS WAS NOT AVAILABLE BUT THE CUSTOMER DID STATE THAT THE MAJORITY OF THE BLOOD LOSS WAS NOT SUBSTANTIAL ENOUGH TO REQUIRE BLOOD TRANSFUSION. THERE MAY HAVE BEEN SOME CHEMO EXPOSURE, BUT NONE REQUIRED EMERGENT CARE OR TREATMENT. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THEY ARE UNABLE TO GIVE ACCURATE INFORMATION ABOUT WHICH BROKEN EXTENSION TUBING (BI/TRI/QUAD FUSE) HAD HARM. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702455 ↗
• MalfunctionMar 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7.5" TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 4 CLAMPS (2 WHITE, BLUE, RED), LUER LOCK WHERE THE CUSTOMER REPORTED THAT THEY HAVE HAD MANY INCIDENTS OF TRIFUSE BREAKING OFF FROM THE LUER CONNECTION. ALL THE BREAKS HAPPENED WHERE THE MALE LUER LOCK INSERTS INTO THE PATIENT¿S MICROCLAVE CAP. THIS RESULTED IN BLOOD LOSS AND IVF LOSS FOR THE PATIENTS, CHEMO SPILLS, AND CAN POTENTIALLY CAUSE HARM FOR THE PATIENTS, HOWEVER, SPECIFIC INFORMATION REGARDING VOLUME OF BLOOD LOSS WAS NOT AVAILABLE BUT THE CUSTOMER DID STATE THAT THE MAJORITY OF THE BLOOD LOSS WAS NOT SUBSTANTIAL ENOUGH TO REQUIRE BLOOD TRANSFUSION. THERE MAY HAVE BEEN SOME CHEMO EXPOSURE, BUT NONE REQUIRED EMERGENT CARE OR TREATMENT. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THEY ARE UNABLE TO GIVE ACCURATE INFORMATION ABOUT WHICH BROKEN EXTENSION TUBING (BI/TRI/QUAD FUSE) HAD HARM. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702350 ↗
• MalfunctionFeb 7, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED WITH REGARDS TO 7.5" TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 4 CLAMPS (2 WHITE, BLUE, RED), LUER LOCK THAT EXPERIENCED BREAKAGE AND LEAKAGE DURING USE. REPORT 2 OF 2. THE REPORTER STATED THAT "ALL THE BREAKS HAPPENED WHERE THE MALE LUER LOCK INSERTS INTO THE PATIENT¿S MICROCLAVE CAP. THEY THINK IT MAY BE A BONDING ISSUE. THIS RESULTED IN BLOOD LOSS AND IVF LOSS FOR THE PATIENTS, CHEMO SPILLS, AND CAN POTENTIALLY CAUSE GREAT HARM FOR THE PATIENTS." ADDITIONALLY THE CUSTOMER STATED THAT "PATIENTS DID NOT SUFFER HARM AS THESE WERE FOUND QUICKLY, BUT THE PATIENT¿S DID LOSE BLOOD AND CHEMO WAS ALSO SPILLED". PRODUCT¿S WERE IN USE, PROVIDING DRUG TREATMENT AT TIME OF INCIDENTS. IVF WAS NOT AN ICU MEDICAL PRODUCT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21339552 ↗
• MalfunctionFeb 7, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED WITH REGARDS TO 7.5" TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 4 CLAMPS (2 WHITE, BLUE, RED), LUER LOCK THAT EXPERIENCED BREAKAGE AND LEAKAGE DURING USE. REPORT 1 OF 2. THE REPORTER STATED THAT "ALL THE BREAKS HAPPENED WHERE THE MALE LUER LOCK INSERTS INTO THE PATIENT¿S MICROCLAVE CAP. THEY THINK IT MAY BE A BONDING ISSUE. THIS RESULTED IN BLOOD LOSS AND IVF LOSS FOR THE PATIENTS, CHEMO SPILLS, AND CAN POTENTIALLY CAUSE GREAT HARM FOR THE PATIENTS." MEDWATCH #(B)(4) ¿PATIENT WAS FOUND WITH BLOOD ON THEIR GOWN. THE TRIFUSE IV ADMINISTRATION SET LUER CONNECTION HAD DETACHED FROM THE PATIENT END OF THE TUBING. IT APPEARS TO BE A BONDING ISSUE AT THE CONNECTION.¿ CHEMOTHERAPY WAS BEING USED ON THE PATIENT AT THE TIME OF THE EVENT AND DATE OF CHEMOTHERAPY IS (B)(6)2024. THE ORIGINAL INTENDED PROCEDURE WAS IV FLUID ADMINISTRATION. THE PROBLEM THAT THE USER HAVE WAS DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). ADDITIONALLY, THE CUSTOMER STATED THAT "PATIENTS DID NOT SUFFER HARM AS THESE WERE FOUND QUICKLY, BUT THE PATIENT¿S DID LOSE BLOOD AND CHEMO WAS ALSO SPILLED". PRODUCT¿S WERE IN USE, PROVIDING DRUG TREATMENT AT TIME OF INCIDENTS. IVF

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21339549 ↗

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-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-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-0242-2021 · Jul 6, 2020 · Terminated
  11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit per pouch, 50 pouches per case. UDI:(01)10887709098937(17)241201(30)50(10)4493669;(01)10887709098937(
• 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-0249-2021 · Jul 6, 2020 · Terminated
  6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per case. UDI:(01)10887709079877(17)250101(30)50(10)4584753;(01)108877090
• Z-0233-2021 · Jul 6, 2020 · Terminated
  139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port NanoClave Manifold w/Check Valve, Spin Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)1088
• 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-0239-2021 · Jul 6, 2020 · Terminated
  APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709070551(17)241201(30)50(10)4542066; (01)10887709070551(17)241201(30)50(1
• Z-0191-2021 · Jul 6, 2020 · Terminated
  5" (13 cm) Appx 0.39 ml, Smallbore Bifuse Ext Set w/NanoClave T-Connector, 2 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053028(17)250101

…and 173 more.