ICU Medical MC33368Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709038141), received between Aug 8, 2024 and Sep 16, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Disconnection” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Break; Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789963 ↗
• MalfunctionFeb 23, 2026Crack; Disconnection

  AN EVENT INVOLVING A 6" BIFUSE EXT SET W/MICROCLAVE® CLEAR, 2 CLAMPS, ROTATING LUER REPORTED THAT THE PATIENT WAS RECEIVING TPN THROUGH A CENTRAL LINE WHEN THE MOTHER NOTICED THAT THE TOTAL PARENTERAL NUTRITION (TPN) HAD BECOME DISCONNECTED FROM BOTH THE CENTRAL LINE AND THE Y-CONNECTOR. THE LINE CONNECTOR WAS FOUND TO BE CRACKED. PATIENT NEEDED TO BE STARTED ON DEXTROSE FLUIDS IMMEDIATELY AS IS TPN DEPENDENT. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24412225 ↗
• MalfunctionAug 8, 2024Material Separation; Material Separation

  AN EVENT INVOLVING A 6" BIFUSE EXT SET W/MICROCLAVE¿ CLEAR, 2 CLAMPS, ROTATING LUER EXPERIENCED DISCONNECTION. AS PER REPORT, THE BRAND NEW Y CONNECTOR WITH BLOOD PORT WAS ADDED TO IV LINE. WHEN BLOOD PORT SIDE OF Y CONNECTOR WAS UNCLAMPED THE TUBING POPPED OUT OF THE Y JUNCTION OPENING THE LINE AND CAUSING BLOOD TO BACKUP IN PIV LINE. PIV IMMEDIATELY CLAMPED BEFORE PATIENT LOST ANY BLOOD, Y CONNECTOR REMOVED FROM PRE-EXISTING LINES AND LINES DEAD ENDED WITH STERILE CAP. MEDICATION ADMINISTRATION WAS DELAYED DUE TO NEED TO MAKE NEW MEDLINE AND PRIME NEW Y CONNECTOR. THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM AND THERE WAS DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938602 ↗

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-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-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-0198-2021 · Jul 6, 2020 · Terminated
  107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709085005(
• Z-0254-2021 · Jul 6, 2020 · Terminated
  22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051967(17)250101(30)50(10)4605591; (01)10
• Z-0214-2021 · Jul 6, 2020 · Terminated
  99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Drop-In Ext, Clave; 1 unit per pouch, 25 pouches per case. UDI: (01)10887709066318(17)241201(30)25(10)4515
• 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-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-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-0199-2021 · Jul 6, 2020 · Terminated
  9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709069340(17)250101(30)50(10)455847

…and 173 more.