ICU Medical MC33098Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709037366), received between Aug 15, 2017 and Nov 24, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A COMPLAINT WAS RECEIVED WITH REGARDS TO A 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 3 CLAMPS, ROTATING LUER TORE DURING USE. IT WAS REPORTED THAT "THIS HOSPITAL HAS REPORTED SEVERAL INSTANCES OF OUR ITEM MC33150 WITH THE SILICONE STUCK DOWN. MOST OF OUR PRODUCT COMPLAINTS INVESTIGATIONS CONCLUDED THAT THE REPORTED ISSUE WAS DUE TO AN INCOMPATIBLE MATING DEVICE. HOWEVER, OUR DEVICE MC33098 IS MOST COMMONLY CONNECTED TO MC33150. DESPITE SEVERAL IV ASSESSMENTS TO TEST ALL PRODUCT IN THE STOREROOM FOR INCOMPATIBILITY WITH MICROCLAVE, WE HAVE NOT BEEN ABLE TO IDENTIFY ANY INCOMPATIBLE SETS THAT COULD BE CONTRIBUTING TO THE ISSUE. WE¿D LIKE FOR YOU TO TEST THE MALE LUER OF MC33098 FOR ANY ANOMALIES THAT COULD BE CONTRIBUTING TO TEARS AND STICKDOWN ON THE CONNECTING MICROCLAVE." THE EVENT DATE UNKNOWN. EVENT OCCURRED UNKNOWN. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM. THE PROBLEM HAS OCCURRED FROM NOVEMBER 2023-PRESENT. THERE HAVE BEEN MULTIPLE EVENTS, BUT THE CUSTOMER DID NOT RECORD THE DATES. THERE WAS A SMALL DELAY IN THERAPY TO REPLACE THE DEFECTIVE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20767053 ↗
• MalfunctionSep 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAMPS, ROTATING LUER THAT THE CUSTOMER REPORTED A PARTIAL DISCONNECTION AND LEAKING RESULTING IN HYPOGLYCEMIA OF A BABY IN THE NICU. THE MEDICATIONS INFUSING WERE TPN, LIPIDS, AND D20W. THE D20W WAS INFUSING FOR ONLY 4 HOURS AND WAS UNKNOWINGLY LEAKING. THE CUSTOMER STATED THE DEVICE WAS IN USE BETWEEN 18 TO 36 HOURS. THE PATIENT¿S STATUS UPON ADMISSION WAS HYPOGLYCEMIA. DURING THE EVENT THE PATIENT WAS BORDERLINE STABLE THEN HYPOGLYCEMIC. THE PATIENT RETURNED TO A NORMOGLYCEMIC STATUS AFTER THE TUBING WAS CHANGED. THE MEDICAL INTERVENTION WAS THE ADMINISTRATION OF D20W AND THE DECREASE OF TPN. THE ENTIRE SET UP WAS CHANGED, NOT THE UMBILICAL VENOUS CATHETER, THE PATIENT¿S SUGAR NORMALIZED WITHIN AN HOUR, AND FEW HOURS LATER THE D20W WAS DISCONTINUED. THE EVENT DID NOT PROLONG THE HOSPITAL STAY.

  Patient problems: Hypoglycemia

  MAUDE report 10572532 ↗
• MalfunctionAug 15, 2017Connection Problem; Connection Problem

  ROTATING LUERS VERY EASILY POPPED OFF ANY AMBULATORY PATIENTS. CAUSED CHEMO SPILL, BLOOD SPILLS, TPN SPILLS AND OTHER MEDICATION AND DRUG SPILLS. UNPROTECTED CHEMO EXPOSURE WAS REPORTED. THE ACTUAL DEVICES WERE NOT RETURNED. THE EXACT CAUSE OF THE EVENTS AND DISCONNECTS REMAIN UNKNOWN. ALTHOUGH THERE WAS AN UNSCHEDULED DEVICE CHANGE OUT THERE WAS NO CRITICAL DELAY IN THERAPY, NO CHANGE IN PATIENT'S BASELINE CLINICAL CONDITION AND NO EMERGENT MEDICAL TREATMENTS OR INTERVENTIONS.

  Patient problems: Chemical Exposure

  MAUDE report 6796073 ↗

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-3157-2026 · May 12, 2026 · Open, Classified
  IV Non-Dedicated Gravity Administration Sets with drip chambers
• Z-3163-2026 · May 12, 2026 · Open, Classified
  IV 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-0205-2021 · Jul 6, 2020 · Terminated
  9.5" (24 cm) Appx 0.56 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709080703(17)250101(30)5
• 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-0186-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051048(17)250101(30)
• Z-0241-2021 · Jul 6, 2020 · Terminated
  6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case. UDI:(01)10887709087719(17)250101(30)50(10)4558621;(01)10887709087719(17)2501
• 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-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-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

…and 173 more.