ICU Medical MC33122Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00887709037403), received between Dec 20, 2023 and Sep 11, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Disconnection” (5 reports).

8 other recalls cover devices cleared under the same FDA submission (K100576); 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.

• MalfunctionSep 11, 2026No Flow

  The event involved a 7" (18 cm) Appx 0.51 ml, Pressure Infusion (400psig) Ext Set w Remv MicroClave Clear, Purple Clamp, Rotating Luer. It was reported that when they hook up the item to the IV tubing, the IV Tubing will not flow. It has caused staff to discard the open item and reopen a new item that works. There was patient involvement but no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50730076 ↗
• MalfunctionSep 10, 2025Disconnection; Disconnection

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.51 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER WHERE IT WAS REPORTED THE PATIENT CAME IN AFTER AN HOUR DUE TO BLINATUMOMAB LINE BREAKING. THE SPINNING SPIROS BECAME DISCONNECTED FROM THE BLINA LINE EVEN THOUGH IT CLICKED IN, AND SHOULD NOT BE ABLE TO COME APART. NEW BLINA BAG AND LINE PRIMED AND RESTARTED. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23020105 ↗
• MalfunctionAug 27, 2024Disconnection; Disconnection

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER. IT WAS STATED ON THE REPORT THAT THERE IS A HIGH RATE INFUSIONS THAT ARE CAUSING THE DEVICE TO POP OFF OF THE IV CATHETER. ONE CAME APART DURING AN IV ANTIBIOTIC INFUSION AND PART OF THE MEDICATION WAS LOST. THERE WAS PATIENT INVOLVED AND UNKNOWN HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077622 ↗
• MalfunctionAug 22, 2024Failure to Infuse; Failure to Infuse

  THE EVENT INVOLVED A 7" PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER, BULK NON-STERILE WHERE IT WAS REPORTED THAT SOME OF THE INTRAVENOUS (IV) START TRAYS HAVE THE WRONG EXTENSION SETS. AS A RESULT, THE FLUSHES WERE NOT ABLE TO WORK ON THE EXTENSION SET AS IT DID NOT LET ANY FLUID GO THROUGH THEM. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND UNKNOWN HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20038001 ↗
• MalfunctionJun 16, 2024Crack; Crack

  IT WAS REPORTED THAT A 7" (18 CM) APPX 0.51 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER WAS FOUND TO HAVE A CRACK AT THE PIGTAIL DURING PATIENT USE. IT WAS REPORTED THE DEVICE WAS CRACKING ON THE PIGTAIL. SAMPLE PICTURES WERE PROVIDED SHOWING THE DEFECTIVE PRODUCT AND THE PACKAGE DETAILS. THERE WAS UNPROTECTED CHEMO EXPOSURE TO THE PATIENT OR HEALTHCARE PROVIDER. THE HEALTHCARE PROVIDER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) OR GLOVES DURING THE EVENT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19545035 ↗
• MalfunctionJun 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A 7" (18 CM) APPX 0.51 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER GENERATED A LEAK DURING PATIENT USE. THE REPORT STATED THAT THIS PRODUCT WAS LEAKING. THE SAMPLE IS AVAILABLE FOR INVESTIGATION. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19544604 ↗
• MalfunctionJun 7, 2024Disconnection; Disconnection

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 7" (18 CM) APPX 0.51 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER. THE CUSTOMER REPORTED THAT THERE ARE HIGH RATE INFUSIONS THAT ARE CAUSING THE DEVICE TO POP OFF OF THE IV CATHETER; ONE CAME APART DURING A BOLUS INFUSION AND INFUSED ONTO BED. THERE WAS PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483952 ↗
• MalfunctionJun 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT WHEN CONNECTING TO NEWLY INSERTED IV CATHETER, BLOOD IS LEAKING AROUND THE DEVICE AT THE IV CATHETER CONNECTION UNLESS IT¿S FORCEFULLY TIGHTENED, WE HAVE HAD SEVERAL OCCURRENCES OF BLOOD LEAKING ONTO THE PATIENT AND BED WHILE PLACING LINES WITH THESE CONNECTORS. THERE WAS PATIENT INVOLVED AND UNKNOWN HUMAN HARM. THE EVENT OCCURRED ON AN UNSPECIFIED DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19465204 ↗
• MalfunctionJun 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A 7" (18 CM) APPX 0.51 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER GENERATED A LEAK DURING PATIENT USE. IT WAS STATED THAT DURING A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAM, THE DISTAL PORTION CONNECTING TO INTRAVENOUS (IV) LEAKS INTO THE ROTATING LUER CAUSING IT TO STOP MID-EXAM AND REPLACE THE EXTENSION MID-STUDY. IT WAS ALSO MENTIONED THAT CONCERN HAD BEEN OCCURRING 70% OF THE TIME AND VERIFIED THAT THIS IS NOT AN OPERATOR ISSUE. IN ADDITION, THE NURSES ARE NOT TIGHTENING THE CONNECTION BETWEEN THE MICROCLAVE AND EXTENSION SET WHEN IT COMES OUT OF THE PACKAGING. THE COLLAR ON THE EXTENSION SET IS INCOMPATIBLE WITH THE BD INSYTE CATHETER. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19442712 ↗
• MalfunctionMay 24, 2024Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 7" (18 CM) APPX 0.51 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER. IT WAS REPORTED THAT THE CONNECTORS ARE HARD TO FLUSH AND SOMETIMES LEAK AND ARE HARD TO CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393318 ↗
• MalfunctionMay 14, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER. THE NURSING DEPARTMENT REPORTED THAT A J-LOOP WAS NOT LUER LOCKING PROPERLY; IT 'COMES UNDONE' AND SUBSEQUENTLY LEAKS. THERE WERE NO INJURIES AND NO ADVERSE EVENTS ASSOCIATED WITH THIS EVENT/COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315316 ↗
• MalfunctionDec 29, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A 7" (18 CM) APPX 0.51 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER GENERATED A LEAK. THE CUSTOMER REPORTED THAT THE EXTENSION SET UNSCREWS ITSELF WHEN ATTACHED TO A 20G PIV VIAVALVE. THE ISSUE WAS NOT DETECTED BEFORE DIRECT PATIENT USE. THERE WAS NO CLINICALLY SIGNIFICANT BLOOD LOSS, NO UNPROTECTED CHEMO EXPOSURE, NO ADVERSE OPERATOR CONSEQUENCES, AND NO MED/SURG INTERVENTION REQUIRED. THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422635 ↗
• MalfunctionDec 20, 2023Disconnection; Disconnection

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.51 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT THE EXTENSION SET MC33122 UNSCREWS ITSELF WHEN ATTACHED TO A 20G PIV VIAVALVE. THE EVENT OCCURRED DURING INFUSION. THERE WAS NO CLINICALLY SIGNIFICANT BLOOD LOSS, NO UNPROTECTED CHEMO EXPOSURE, NO ADVERSE OPERATOR CONSEQUENCES, NO MED/SURG INTERVENTION REQUIRED. THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS PATIENT INVOLVEMENT, NO SERIOUS INJURY/DEATH, AND THERE WAS DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18362974 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100576. One submission often covers many models, so check the product and lot details in each record.

• Z-3160-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-1720-2022 · Aug 1, 2022 · Open, Classified
  8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
• Z-0193-2021 · Jul 6, 2020 · Terminated
  6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purple Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouche
• Z-0192-2021 · Jul 6, 2020 · Terminated
  9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connector, 3 Purple Clamps, Rotating Luer. 1 unit per pouch, 50 mul
• Z-0197-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring), Rotating Luer; unit per pouch, 50 multi
• Z-0204-2021 · Jul 6, 2020 · Terminated
  6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per
• Z-0201-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case.
• Z-1916-2020 · Oct 4, 2019 · Terminated
  REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00887709026889