ICU Medical, Inc. MC33332Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00887709037816), received between Aug 23, 2023 and Mar 9, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “No Flow” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Fluid/Blood Leak

  AN EVENT INVOLVING A 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE CLEAR, DUAL CHECK VALVE, SMALLBORE BIFUSE EXT SET W/MICROCLAVE CLEAR (GREEN RING), 0.2 MICRON FILTER, ROTATING LUER WAS REPORTED THAT THE PRODUCTS WERE LEAKING AT THE BAG SPIKE. THEY NOTED PUDDLE ON GROUND AND WET TUBING. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543225 ↗
• InjuryMar 5, 2026Backflow

  THE EVENT INVOLVED A 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE CLEAR, DUAL CHECK VALVE, SMALLBORE BIFUSE EXT SET W/MICROCLAVE CLEAR (GREEN RING), 0.2 MICRON FILTER, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE DEVICE BACK FLOWED INTO THE BAG WHEN THE PATIENT END OF THE TUBING IS CLAMPED. THE PATIENT WAS STARTED ON A DEXTROSE SECONDARY INFUSION AND GIVEN ONE DEXTROSE BOLUS. THERE WAS PATIENT INVOLVEMENT AND PATIENT EXPERIENCED LOW URINE OUTPUT AND LOW GLUCOSE LEVELS. THE PATIENT WAS REPORTED TO BE STABLE AFTER THE EVENT.

  Patient problems: Hypoglycemia

  MAUDE report 24527024 ↗
• MalfunctionFeb 10, 2026No Flow

  AN EVENT INVOLVED A 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE CLEAR, DUAL CHECK VALVE, SMALLBORE BIFUSE EXT SET W/MICROCLAVE CLEAR (GREEN RING), 0.2 MICRON FILTER, ROTATING LUER REPORTED THAT THE PATIENT HAD A PERIPHERAL IV (INTRAVENOUS) FOR ANTIBIOTIC ADMINISTRATION AND A TYPICAL BIFUSE EXTENSION SET WAS USED. ON DAY SHIFT IT HAD BEEN NOTED THAT THE PUMP WOULD OCCASIONALLY RING OFF AS LINE OCCLUDED, BUT ALARM WAS RESOLVED BY REPOSITIONING BABY'S ARM, THEY SAID THAT IT WAS FELT THAT IT WAS LIKELY A POSITIONAL IV OR AN ISSUE WITH THE ALARIS PUMP ITSELF AS THE IV SITE ASSESSED WELL. ON WRITER'S SHIFT, IV WOULD RING OCCLUDED INTERMITTENTLY EVERY FEW HOURS. THE IN-CHARGE NURSE CONTINUED TO ASSESS IV SITE, WHICH LOOKED PERFECT, AND DISCONNECTED FROM IV EXTENSION SET AND WAS ABLE TO FLUSH IV WELL. THEY DISCONNECTED LINES FROM THE PUMP AND OPENED THE CLAMP FULLY ON THE LINE TO RUN FLUID WIDE OPEN TO TEST THE LINES AND NO FLUID CAME OUT. WHEN THEY DISCONNECTED THE D10W (DEXTROSE) LINE FROM THE GREEN BIFUSE CONNECTION PORT, D10W FLUID FLOWED FREELY. IT APPEARS THERE MAY HAVE BEEN A DEFECT OR ISSUE WITH THE LINE BETWEEN THE GREEN BIFUSE PORT AND THE FILTER OR PERHAPS AN ISSUE IN T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301216 ↗
• MalfunctionOct 15, 2025No Flow; No Flow

  ONE OF THE INSTANCES HAPPENED IN MAY (STILL UNSPECIFIED DATE) WAS DURING THAT EVENT, THE UPPER CLAMP ON THE CLOSED MEDICATION SET WAS NOT SECURED, AND THE TPN WAS INFUSING VIA MEDFUSION SYRINGE PUMP AT 11 ML/HR. WHEN THE SET WAS REPLACED, A SMALLER SYRINGE VOLUME SYRINGE WAS ATTACHED AND THE UPPER CLAMP WAS SECURED, RESOLVING THE ISSUE. THE ORIGINAL SETUP UTILIZED A 50 ML SYRINGE. THE CHILD EXPERIENCED DECLINES IN BLOOD GLUCOSE LEVELS (BGL) AND URINARY OUTPUT (UOP) DUE TO INADEQUATE IV FLUID DELIVERY.

  Patient problems: Hypoglycemia

  MAUDE report 23281888 ↗
• MalfunctionNov 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, SMALLBORE BIFUSE EXT SET W/MICROCLAVE® CLEAR (GREEN RING), 0.2 MICRON FILTER, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE BIFUSE 0.2 MICRON FILTER WAS FOUND LEAKING. THE SET REPLACED AND WITHIN 1 HOUR THE BIFUSE 0.2-MICRON FILTER ON THE NEW SET WAS FOUND LEAKING. NO EXCESSIVE PRESSURE WAS USED TO PRIME THE SET. SET REPLACED AND BOTH SETS RETAINED. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENTS REPORTED. THIS IS THE FIRST OF TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18162457 ↗
• MalfunctionNov 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, SMALLBORE BIFUSE EXT SET W/MICROCLAVE® CLEAR (GREEN RING), 0.2 MICRON FILTER, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE BIFUSE 0.2 MICRON FILTER WAS FOUND LEAKING. THE SET REPLACED AND WITHIN 1 HOUR THE BIFUSE 0.2-MICRON FILTER ON THE NEW SET WAS FOUND LEAKING. NO EXCESSIVE PRESSURE WAS USED TO PRIME THE SET. SET REPLACED AND BOTH SETS RETAINED. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENTS REPORTED. THIS IS THE SECOND OF TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18162454 ↗
• MalfunctionNov 14, 2023Precipitate in Device or Device Ingredient; No Flow; Precipitate in Device or Device Ingredient; No Flow

  THE EVENT INVOLVED A 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, SMALLBORE BIFUSE EXT SET W/MICROCLAVE® CLEAR (GREEN RING), 0.2 MICRON FILTER, ROTATING LUER. IT WAS REPORTED THAT THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MEDLINE RINGING OCCLUSION WITH POST FLUSH ADMINISTRATION IN PROGRESS, INTRAVENOUS FLUID (IVF) LINE INFUSING WELL IN THE ALARIS PUMP. STAFF AT THE BEDSIDE NOTED PRECIPITATE IN BIFUSE FILTER. IVF LINE CHANGED DOWN TO PICC LINE CLAVE 2 DAYS EARLY. IMPACT OF THE INCIDENT REQUIRED IVF LINE CHANGE EARLY. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132210 ↗
• MalfunctionAug 23, 2023Device Contamination with Chemical or Other Material; No Flow; Device Contamination with Chemical or Other Material; No Flow

  THE REPORTED COMPLAINT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, SMALLBORE BIFUSE EXT SET W/MICROCLAVE® CLEAR (GREEN RING), 0.2 MICRON FILTER, ROTATING LUER. THE CUSTOMER REPORTED THAT PER THEIR TROUBLESHOOTING, IT WAS REVEALED THAT THE IV TUBING CAUSED THE SYRINGE PUMP TO RING AS OCCLUDED AND IT WAS NOT DUE TO THE PIV ITSELF CAUSING ANY HIGH PRESSURE. THE GREEN AIR FILTER 0.2 MICRON FILTER HAD WHITE PRECIPITATE IN IT. THE PATIENT WAS ON PENICILLIN G WITH A NORMAL SALINE MED LINE ONLY USED FOR MEDICINE ADMINISTRATION, NOT CONTINUOUS INFUSIONS. THE IMPACT OF THE INCIDENT IS THAT A NEW BIFUSE WAS HUNG AND THE REMAINDER OF MEDICINE WAS GIVEN VIA NEW LINE. THERE WAS NO APPARENT HARM THAT REACHED A PERSON. THIS EMDR REFLECTS THE SECOND OF TWO OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17602681 ↗
• MalfunctionAug 23, 2023Device Contamination with Chemical or Other Material; No Flow; Device Contamination with Chemical or Other Material; No Flow

  THE REPORTED COMPLAINT INVOLVED A 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, SMALLBORE BIFUSE EXT SET W/MICROCLAVE® CLEAR (GREEN RING), 0.2 MICRON FILTER, ROTATING LUER. THE CUSTOMER REPORTED THAT PER THEIR TROUBLESHOOTING, IT WAS REVEALED THAT THE IV TUBING CAUSED THE SYRINGE PUMP TO RING AS OCCLUDED AND IT WAS NOT DUE TO THE PIV ITSELF CAUSING ANY HIGH PRESSURE. THE GREEN AIR FILTER 0.2 MICRON FILTER HAD WHITE PRECIPITATE IN IT. THE PATIENT WAS ON PENICILLIN G WITH A NORMAL SALINE MED LINE ONLY USED FOR MEDICINE ADMINISTRATION, NOT CONTINUOUS INFUSIONS. THE IMPACT OF THE INCIDENT IS THAT A NEW BIFUSE WAS HUNG AND THE REMAINDER OF MEDICINE WAS GIVEN VIA NEW LINE. THERE WAS NO APPARENT HARM THAT REACHED A PERSON. THIS EMDR REFLECTS THE FIRST OF TWO OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17602634 ↗

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-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-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-0232-2021 · Jul 6, 2020 · Terminated
  58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case. UDI:(01)10887709095298(17)250101(30)25(10)4573460
• 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-0211-2021 · Jul 6, 2020 · Terminated
  5.5" (14 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 MicroClave" Clear, NanoClave" T-Connector, 3 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case.UDI:(01)
• Z-0237-2021 · Jul 6, 2020 · Terminated
  20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709069203(17)250201(30)50(10)4742130; (01)10887709069203(1
• Z-0251-2021 · Jul 6, 2020 · Terminated
  60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040103(17)250201(30)50(10)4726780. The Intravascular Ad
• Z-0188-2021 · Jul 6, 2020 · Terminated
  10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri-Connector, NanoClave T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer;1 unit per pouch, 50 multivac pouche
• 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

…and 173 more.