ICU Medical MC33213Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00887709037519), received between Jun 28, 2024 and Mar 20, 2026 — classified as 54 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (45 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 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Fluid/Blood Leak

  A '7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER' REPORTEDLY SQUIRTED OUT SALINE FROM THE CONNECTION BETWEEN THE MICROCLAVE AND THE J LOOP TUBING OF A MATING DEVICE AFTER IT WAS ATTACHED FOR THE PATIENT. THE J-LOOP DEVICE WAS FLUSHED PRIOR TO INSERTING THE IV FOR A PATIENT. THE CLINICIAN TIGHTENED THE CONNECTION AND IT WAS STILL LEAKING. FINALLY, A NEW J LOOP DEVICE WAS THEN FLUSHED AND CONNECTED WITH NO LEAKING NOTED. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651233 ↗
• MalfunctionMar 19, 2026Fluid/Blood Leak

  LEAKAGE OF AN UNSPECIFIED FLUID/INFUSATE WAS REPORTED AT THE HUB SITE OF A 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER DIRECTLY AFTER STAFF STARTED THE PATIENT'S IV. THEY ATTEMPTED TO TAKE THE J-LOOP TUBING OFF AND THE TOP PART OF IT BROKE OFF. ALTHOUGH THEY EVENTUALLY GOT THE J-LOOP OFF THE PATIENT, THEY ALMOST HAD TO START ANOTHER IV. WHEN ATTEMPTING TO TROUBLE SHOOT THE LEAKAGE, THE PRODUCT BROKE. THERE WAS AN UNSPECIFIED DELAY OF TREATMENT FOR THE PATIENT WHILE THE USER ATTEMPTED TO IDENTIFY AND RECTIFY THE LEAK. THERE WERE NO NEGATIVE EFFECTS OR HARM TO THE PATIENT DUE TO THE DELAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644039 ↗
• MalfunctionFeb 18, 2026Fluid/Blood Leak

  AN EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A SMALLBORE PRESSURE INFUSION EXT SET WITH REMV MICROCLAVE CLEAR, PURPLE CLAMP, ROTATING LUER REPORTED THAT HAVE BEEN BROKEN. THEY WERE NOT BROKEN VISUALLY BUT LEAK AFTER BEING ATTACHED TO PIV AND FLUSHED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24375521 ↗
• MalfunctionDec 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN INCIDENT WAS REPORTED WITH A SMALLBORE PRESSURE INFUSION EXTENSION SET IN WHICH FLUID WAS LEAKING AT THE CONNECTION POINT BETWEEN THE MICROCLAVE CAP AND THE LOOP. THE MICROCLAVE CAP WAS FIRST REPLACED WITH ONE FROM ANOTHER J-LOOP OF THE SAME LOT, BUT THE LEAK PERSISTED WHEN FLUSHED WITH 0.9% NORMAL SALINE. MICROCLAVE CAP CHANGED AGAIN FROM A SINGLE MICROCLAVE CAP PACKAGE AND CONTINUED TO LEAK. ENTIRE SET UP CHANGED TO A Y-CONNECTOR AND THEN THERE WAS NO LONGER A LEAK. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23904083 ↗
• MalfunctionOct 28, 2025Crack; Fluid/Blood Leak; Fracture; Crack; Fluid/Blood Leak; Fracture

  LEAKAGE WAS REPORTED FROM A 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER DEVICE. IT WAS REPORTED THAT A MIDLINE IV CATHETER WAS INSERTED INTO PATIENT, AND THE PRODUCT WAS ATTACHED TO END OF THE LINE FOR PURPOSES OF FLUSHING. LEAKAGE OF FLUID FROM EXTENSION SET WAS THEN IDENTIFIED FROM A SMALL CRACK NEAR REMV MICROCLAVE. THE DEVICE WAS REMOVED FROM THE LINE AND REPLACED WITH ANOTHER, FUNCTIONAL EXT. SET. THERE WERE NO HARM AND NO DELAY IN CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404677 ↗
• MalfunctionSep 4, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  EVENT OCCURRED ON AN UNSPECIFIED DATE REGARDING 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER WHERE THE REPORT STATE "CRACK HUB AND LEAKING AT THE CONNECTION OF THE MICROCLAVE TO THE EXTENSION SET. REPORT CAPTURES 3 OCCURRENCES. THERE WERE UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963454 ↗
• MalfunctionSep 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER WHILE THE NURSE WAS ASSESSING IV MID TRANSFUSION FOR PATIENT. THEY STATED THAT "UPON ARRIVAL TO BEDSIDE. RN NOTED TWO DROPS OF FRANK RED BLOT ON PATIENT'S FOREARM. UPON FURTHER INVESTIGATION, THE IV SITE WITH UNREMARKABLE. WHEN RETRACING THE TUBING, IT WAS FOUND TO BE LEAKING AT THE MAX CAP CONNECTED TO THE I-CONNECTOR. RN TIGHTENED MAX CAP AND RESTARTED TRANSFUSION. LEAKING STILL NOTED AT MAX CAP.". THERE WERE PATIENT INVOLVEMENT, UNKNOWN HUMAN HARM AND UNKNOWN DELAY IN THERAPY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951868 ↗
• MalfunctionAug 5, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MULTIPLE COMPLAINTS WERE REPORTED THAT INVOLVED A 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER. LEAKAGE OF AN UNSPECIFIED FLUID/INFUSATE WAS REPORTED WHERE THE J-LOOP AND THE MICROCLAVE MEET DURING PATIENT USE. -REPLACED THE J-LOOP AND MICROCLAVE. -FOUND A CRACK IN THE J-LOOP AFTER REMOVING. THE CUSTOMER EXPRESSED CONCERNS REGARDING OPEN FLUID PATHWAYS THAT PUT THE PATIENT AT INCREASED RISK FOR CATHETER RELATED BLOOD STREAM INFECTION. -EXTRA LINE ENTRIES WERE REQUIRED. THE AFFECTED AREA/UNIT LOCATION WAS AT MCSA. THERE WERE NO OTHER DEVICES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS NO REPORT OF ANY SPECIFIC PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716663 ↗
• MalfunctionJul 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER THAT EXPERIENCED LEAKAGE DURING USE. "THE REPORTER STATED THAT UPON ENTERING ISOLATE FOR 1800 CARE, THIS RN FOUND BLOOD TO BE BACKING UP INTO PATIENTS PICC LINE. STERILE DRAPE PLACED, SCRUB HUB USED, AND LINE PLACED. WHEN FLUSHED, WATER CAME OUT OF J LOOP. LINE CLAMPED, NNP NOTIFIED. FLUIDS SWITCHED TO STARTER D10, AND BLOOD CULTURES AND CBC DRAWN. THE EVENT DATE WAS ON 09-JUN-2025 OCCURRED DURING USE FOR PATIENT CARE IN (B)(6). THE PATIENT IS A 0.09-YEAR MALE. NO OTHER DEVICES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538477 ↗
• MalfunctionJul 1, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  UPDATE: A MEDSUN MEDWATCH UF/IMPORTER REPORT # (B)(4) WAS RECEIVED ON 06-AUG-2025 THAT IS ASSOCIATED WITH THIS SPECIFIC REPORTED COMPLAINT/EVENT. THE LOCATION WHERE THE EVENT OCCURRED WAS AT HOSPITAL NICU.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22373922 ↗
• MalfunctionJun 30, 2025Crack; Crack

  THE REPORTED ISSUE OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER. THE REPORT STATED THAT THEY USED A FLUSH SYRINGE TO TEST THE FAILURE AND DIAGNOSED WHAT APPEARS TO BE A CRACK IN THE FEMALE LUER CONNECTOR. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22354929 ↗
• MalfunctionJun 18, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED LEAKING AT THE CONNECTION TO PERIPHERAL INTRAVENOUS (PIV) CATHETER WHEN FLUSHED TO 2 J-LOOPS WHEN PUTTING IN PIV. THE INCIDENT OCCURRED NICU MCSA BUT THE ORIGINAL PROCEDURE INTENDED WAS UNKNOWN. THE CUSTOMER STATED THAT THERE WERE NO OTHER DEVICES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS PATIENT INVOLVEMENT, HOWEVER, HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285347 ↗
• MalfunctionJun 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE DEVICE FAILED TWICE IN THE ¿BATTLE BUILDING.¿ THE CUSTOMER PROVIDED ADDITIONAL INFORMATION STATING THAT THERE WAS WASTED FLUIDS AND MEDICATIONS (UNSPECIFIED) THAT COME IN CONTACT WITH THE PATIENT AND THE BEDDING/SHEETS ALLUDING TO LEAKAGE OF THE DEVICE, BUT WITH MINIMAL IMPACT. THE CUSTOMER CONFIRMED THAT THERE WAS NO HAZARDOUS MEDICATION SPILL. THERE WAS PATIENT INVOLVEMENT AND A DELAY IN THERAPY, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206627 ↗
• MalfunctionJun 13, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE CLEAR, PURPLE CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT THE EXT SET LEAKED AT CONNECTION TO PERIPHERAL INFUSION CATHETER. PIV PLACED SUCCESSFULLY, AND UPON NOTICE OF LEAK, TUBING WAS DISCONNECTED AND EXT SET REMOVED TO CONNECT IV FLUIDS TO CATHETER. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202811 ↗
• MalfunctionJun 12, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER WHERE IT WAS REPORTED THE DEVICE HAD A CRACK AND LEAKED. A PATIENT WAS HAVING A GI PROCEDURE AND WAS RECEIVING SEDATION AND IV FLUIDS. IT WAS REPORTED THE PERIPHERAL INTRAVENOUS (PIV) TUBING WAS HOOKED UP TO THE PATIENT, ANESTHESIA WENT TO PUSH MEDICATIONS THROUGH IT, THE MEDS AND FLUID STARTED TO SPRAY OUT OF THE SIDE OF THE J LOOP PLASTIC PIECE THAT CONNECTS INTO THE MEDICATION LUER LOCK CAP ON IT. IT WAS THEN NOTICED THERE WAS A CRACK, HOWEVER, THIS WAS NOT NOTICED DURING PRIMING. THERE WERE NO OTHER DEVICES BEING USED ON A PATIENT AT THE TIME OF EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193584 ↗
• MalfunctionMay 31, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER THAT EXPERIENCED LEAKAGE DURING USE. THE REPORT STATES THAT "BEDSIDE RN WAS CHANGING TUBING AND HAD BLOOD BACKING UP INTO THE LINE. LINE BEGAN LEAKING WITH FLUSH AND RN NOTICED CRACKED EXTENSION TUBE". THE PATIENT INVOLVED IS A 0.04 YEAR OLD MALE. THE PACKAGING WAS NOT SAVED. NO OTHER DEVICES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. SAMPLE WAS AVAILABLE FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT. NCH TRACKING NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22120352 ↗
• MalfunctionMay 16, 2025Leak/Splash; Leak/Splash

  THE COMPLAINT/EVENT INVOLVED A 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER. THE REPORTER STATED THAT UPON FLUSHING THE PERIPHERAL INTRAVENOUS CATHETER (PIV), FLUSH SOLUTION SPRAYED OUT OF THE EXTENSION PIECE "J LOOP" (JUST BELOW THE MICROCLAVE CLAMP). THE EXTENSION PIECE WAS CHANGED SUCCESSFULLY WITHOUT LOSING THE PIV. THERE WAS NO ADVERSE EVENT OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040488 ↗
• MalfunctionMay 5, 2025Separation Problem; Separation Problem

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE PRODUCT WAS BROKE OFF. THERE WAS UNKNOWN PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962991 ↗
• MalfunctionMay 5, 2025Break; Crack; Fluid/Blood Leak; Break; Crack; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE PRODUCT WAS BROKEN OFF; IT WAS NOT OBVIOUS UNTIL THEY CONNECTED TO THE IV CATHETER AND HAD BLOOD EXPOSURE. THERE WAS UNKNOWN PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962529 ↗
• MalfunctionMay 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING AN UNSPECIFIED ICU MEDICAL CLAVE THAT EXPERIENCED LEAKAGE DURING PATIENT USE. IT WAS REPORTED THAT THE CLAVE, WHICH WAS ATTACHED TO THE END OF CENTRAL LINE, WAS FOUND TO BE LEAKING ON THE INSIDE WITH TPN AND LIPIDS. THE CLAVE WAS REMOVED AND REPLACED. THE NUMBER OF OCCURRENCES IS TWO. THE CLAVE WAS ATTACHED TO THE END OF A CENTRAL LINE AND FOUND TO BE LEAKING; UPON DISCOVERY CLAVE WAS IMMEDIATELY REMOVED AND REPLACED. PHOTO OF THE ACTUAL DEFECTIVE PRODUCT WAS PROVIDED (TPN/LIPIDS WAS FOUND INSIDE OF THE CLAVE). THERE WAS NO HARM AS A RESULT OF THE EVENT, HOWEVER, DID REQUIRE ACCESS TO THE STERILE, CENTRAL LINE TO REPLACE THE CLAVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945123 ↗
• MalfunctionApr 29, 2025Crack; Crack

  A COMPLAINT WAS RECEIVED REGARDING A TO 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER THAT EXPERIENCED CRACK. THE REPORT STATES THAT THERE IS A SMALL CRACK IN J LOOP ¿ CLOSEST TO PARENT. THE INVOLVED PATIENT IS 0-DAY-OLD MALE. THE AFFECTED AREA/UNIT LOCATION IS IN MCSA NICU. THE PACKAGING WAS SAVED. THIS IS NOT A SINGLE USE DEVICE THAT WAS REPROCESSED AND REUSED ON A PATIENT. SAMPLE WAS AVAILABLE FOR EVALUATION. THE DEVICE WILL BE RETURNED VIA THE MANUFACTURER¿S PREFERRED RETURN PROCESS. THE DEVICE INVOLVED IN THIS EVENT WAS NOT AVAILABLE IN THEIR FACILITY. DATE OF OCCURRENCE WAS ON 14-MAR-2025. IT WAS IN USE FOR PATIENT CARE. NO OTHER DEVICES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931478 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER WHERE THE REPORTER STATED THAT WHEN THE NURSE (RN) HAND FLUSHED PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE DURING LINE CHANGE, THE FLUID LEAKED FROM POSI FLOW OF THE NEW I-CONNECTOR THAT WAS JUST CHANGED. THE PATIENT INVOLVED IS A 0.04 FEMALE AND WITH POTENTIAL HARM. NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734785 ↗
• MalfunctionMar 21, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A 7" SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER, BULK NON-STERILE THAT EXPERIENCED CRACK AND LEAKAGE. IT WAS REPORTED THAT THE EXTENSION SET CONNECTED TO IV CATHETER IN PATIENT. BLOOD WAS FOUND TO BE ON SHEETS AND EXTENSION SET NOTED TO BE LEAKING FROM A CRACK IN LUER LOCK HUB. EXTENSION SET REMOVED AND NEW EXTENSION SET WAS CONNECTED TO IV CATHETER. THERE IS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21667670 ↗
• MalfunctionMar 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER THAT EXPERIENCED LEAKAGE. THE REPORTER STATED THAT LEAKING WAS NOTED FROM TUBING, AND A NEW IV NEEDED WAS PLACED DUE TO UNABLE TO DISCONNECT. THE PATIENT INVOLVED WAS 17.14 YEARS OLD AND FEMALE. THE AFFECTED AREA OR UNIT LOCATION WAS CT/CAT SCAN. THUS, THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM AND UNKNOWN DELAY IN THERAPY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661198 ↗
• MalfunctionMar 17, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER EXPERIENCED CRACKED AND LEAKAGE. IT WAS STATED IN THE REPORT IV TUBING CONNECTOR PIECE CRACKED. THE PATIENT HAD A PERIPHERAL IV PLACED, AND TUBING CONNECTED WHEN IT WAS SEEN TO BE LEAKING AT THE CONNECTION BETWEEN THE TUBING AND THE MICROCLAVE CAP. A NEW CONNECTOR WAS ADDED FROM THE SAME LOT AND DID NOT LEAK. THERE WAS 16.99 OLD MALE PATIENT INVOLVED, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21627439 ↗

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-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-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-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-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-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