ICU Medical MC33150Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00887709037441), received between Jul 11, 2023 and Jul 31, 2026 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (21 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50104332 ↗
• MalfunctionApr 29, 2026Fluid/Blood Leak

  THE FOLLOWING MEDICAL DEVICE '7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER' REPORTEDLY CAME APART DURING A PATIENT'S BLOOD TRANSFUSION AT HOSPITAL, LEADING TO EXTENSIVE (ALTHOUGH NOT QUANTIFIED) BLOOD LOSS. THERE WAS A SHORT DELAY TO REPLACE THE BLOOD LOST FOR THE PATIENT, AND THIS INCREASED THE TIME REQUIRED TO COMPLETE THE TRANSFUSION. THERE ARE NO FURTHER DETAILS AVAILABLE REGARDING THE INCIDENT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031662 ↗
• MalfunctionFeb 26, 2026Fluid/Blood Leak

  AN EVENT INVOLVING A 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER REPORTED THAT ON TWO SEPARATE OCCASIONS WITHIN LESS THAN ONE WEEK, AFTER THE EXTENSION SET WAS CONNECTED TO A PATIENT¿S INTRAVENOUS (IV) LINE AND A FLUSH WAS COMPLETED AND DISCONNECTED, THE PATIENT¿S BLOOD RAPIDLY REFLUXED INTO THE TUBING AND THEN FLOWED OUT THROUGH THE MICROCLAVE CONNECTOR ONTO THE FLOOR. IT WAS ALSO MENTIONED THAT THE CONNECTOR WAS ACCESSED ONCE AT THE TIME THE IV WAS PLACED (SALINE). THE CONNECTOR WAS ACCESSED WITH A 20G VIAVALVE NEEDLE (SMITH MEDICAL JELCO) AND 10ML PRELOADED SALINE FLUSH (BD POSIFLUSH SP). THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED. THE EVENT OCCURRED ON TWO DIFFERENT DATES, AND THIS REPORT CAPTURES SECOND OF TWO INCIDENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24451364 ↗
• MalfunctionFeb 26, 2026Fluid/Blood Leak

  AN EVENT INVOLVING A 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER REPORTED THAT ON TWO SEPARATE OCCASIONS WITHIN LESS THAN ONE WEEK, AFTER THE EXTENSION SET WAS CONNECTED TO A PATIENT¿S INTRAVENOUS (IV) LINE AND A FLUSH WAS COMPLETED AND DISCONNECTED, THE PATIENT¿S BLOOD RAPIDLY REFLUXED INTO THE TUBING AND THEN FLOWED OUT THROUGH THE MICROCLAVE CONNECTOR ONTO THE FLOOR. IT WAS ALSO MENTIONED THAT THE CONNECTOR WAS ACCESSED ONCE AT THE TIME THE IV WAS PLACED (SALINE). THE CONNECTOR WAS ACCESSED WITH A 20G VIAVALVE NEEDLE (SMITH MEDICAL JELCO) AND 10ML PRELOADED SALINE FLUSH (BD POSIFLUSH SP). THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED. THE EVENT OCCURRED ON TWO DIFFERENT DATES, AND THIS REPORT CAPTURES FIRST OF TWO INCIDENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24451362 ↗
• MalfunctionJan 28, 2026Fluid/Blood Leak; Patient Device Interaction Problem

  THE EVENT INVOLVED A EXT SET W/MICROCLAVE CLEAR, PURPLE CLAMP, ROTATING LUER AND IT WAS REPORTED THAT WHEN AN INTRAVENOUS (IV) WAS STARTED ON THE PATIENT, THE EXTENSION SET THAT WAS ATTACHED, THE CLAVE ON THE END NOT ATTACHED TO THE PATIENT WAS STUCK IN AN OPEN POSITION. THE NURSE NOTICED THE BLOOD DRIPPING OUT OF THE END OF THE EXTENSION SET QUICKLY, AND THEY WERE ABLE TO STOP THE BLEEDING QUICKLY AND SWITCH TO A DIFFERENT SET THAT DIDN'T HAVE A PROBLEM. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24197847 ↗
• MalfunctionOct 16, 2025Crack; Crack

  THE EVENT INVOLVED A 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT BLOOD FOUND IN CLOSED SYSTEM IV EXTENSION SYSTEM. THE BLOOD GOT INTO THE MICROCLAVE CAP OF THE IV EXTENSION SET WHILE BEING USED IN CONJUNCTION WITH AN ARTERIAL LINE. CHANGING THE MICROCLAVE EXTENSION SET WAS RISKY FOR THE 23-WEEK GESTATION INFANT. THE MICROCLAVE EXTENSION SET WAS CONNECTED DIRECTLY TO THE ARTERIAL LINE. THERE WAS A SMALL CRACK IN THE MICROCLAVE CAP. THERE WAS REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316921 ↗
• MalfunctionOct 15, 2025Crack; Crack

  THE EVENT OCCURRED ON UNSPECIFIED DAY IN (B)(6) 2025 INVOLVING A 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER. IT WAS REPORTED THAT BLOOD WAS FOUND IN CLOSED SYSTEM IV EXTENSION SYSTEM. THERE WAS A SMALL CRACK IN THE MICROCLAVE CAP. THERE WAS REPORTED PATIENT INVOLVEMENT, BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303220 ↗
• MalfunctionJul 14, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER. THE REPORTER STATED THAT THEY WENT TO HANG NEW DOSE OF BLINA AT 1815 ON AN IV, NOT A PORT. UPON UNHOOKING THE BIFUSE, THEY NOTICED THAT BLOOD STARTED BACK PRIMING FROM IV. SINCE THEY'RE NOT SUPPOSED TO FLUSH BLINA, THEY JUST CONNECTED THE TUBING TO THE IV AND STARTED THE BLINA. THE BLOOD CLEARED FROM THE LINE. AT 1900, PT CALLED AND TOLD THAT THE TUBING JUST STARTED LEAKING. THEY CALLED THE IV TEAM TO COME IMMEDIATELY TO LOOK AT THE IV. SINCE THEY GOT GREAT BLOOD RETURN, THEY DIDN'T WANT TO PLACE A NEW IV, BUT THEY CHANGED THE IV TUBING. THEY FOUND THAT THE CLAVE ATTACHED TO THE IV TUBING WAS CRACKED. THEY DIDN'T FLUSH ANY BLINA BUT ONLY GOT A NEW TUBING TO CONNECT TO THE OLD IV THEN FLUSHED WITH THE NEW SALINE LINE. THE BLINA WAS PAUSED FROM 1900-1915 WHEN IV GOT THERE. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS VNO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22502186 ↗
• MalfunctionJun 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER WHERE IT WAS REPORTED THE TECHNOLOGIST SET UP THE PATIENT WITH AN IV INCLUDING THE EXTENSION SET. WHILE FLUSHING THE LINE TO ENSURE THE IV WAS PATENT, THE EXTENSION SET WAS LEAKING, AND THE TECH CHANGED THE LINE PRIOR TO INJECTION. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT. THE LINE ONLY HAD SALINE FLUSHED THROUGH IT WHEN IT STARTED LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22357644 ↗
• MalfunctionJun 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER WHERE IT WAS REPORTED THE TECHNOLOGIST SET UP THE PATIENT WITH AN IV INCLUDING THE EXTENSION SET. WHILE FLUSHING THE LINE TO ENSURE THE IV WAS PATENT, THE EXTENSION SET WAS LEAKING. THE TECH CHANGED THE LINE PRIOR TO INJECTION. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT. SALINE AND FDG WAS USED IN THIS LINE (THE RADIOACTIVITY FROM THE FDG HAS DECAYED TO THE POINT WHERE IT IS SAFE TO HANDLE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22357417 ↗
• MalfunctionJun 12, 2025Leak/Splash; Leak/Splash

  THE COMPLAINT INVOLVED A 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE CLEAR, PURPLE CLAMP, ROTATING LUER. THE REPORTER STATED THAT RADIOACTIVE MATERIAL SPRAYED ONTO TECHNOLOGIST WHEN THEY WENT TO INJECT TC99. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO HARM REPORTED. THERE WAS MINIMAL DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193979 ↗
• MalfunctionMay 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT WHILE ADMINISTERING A DOSE OF THERAPEUTIC LU PSMA THERE WAS A LEAK SOMEWHERE DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, AND NO ADVERSE EVENT WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21998089 ↗
• MalfunctionApr 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER. THE CONNECTOR OF THE DEVICE REPORTEDLY LEAKED AN UNSPECIFIED FLUID/INFUSATE. THEY COMPLAINED OF HAVING TROUBLES WITH THEIR STOP-COCKS AND IV CONNECTORS IN NUCLEAR MEDICINE AND PET/CT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21914480 ↗
• MalfunctionApr 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER. THE REPORTER STATED THAT THERE WAS A CONNECTOR MALFUNCTION, SPECIFICALLY THAT IT LEAKED AN UNSPECIFIED FLUID/INFUSATE. THEY HAVE BEEN EXPERIENCING TROUBLES WITH THEIR STOP-COCKS AND IV CONNECTORS IN NUCLEAR MEDICINE AND PET/CT. THERE WAS NO PROCEDURE AND NO SPECIFIC PATIENT AFFECTS REPORTED. THE LEVEL OF HARM WAS UNKNOWN THOUGH THERE WAS NO SERIOUS HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900966 ↗
• MalfunctionApr 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER WAS FOUND TO HAVE GENERATED A LEAK DURING PATIENT USE. IT WAS REPORTED THAT THE PATIENT WAS SET UP WITH AN INTRAVENOUS (IV) AND SMALLBORE PRESSURE INFUSION EXTENSION SET. AT THE TIME OF THE INJECTION, THE EXTENSION SET STARTED TO LEAK AT THE CONNECTION END. THERE WAS UNSPECIFIED UNEXPECTED OR PROLONGED CARE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860967 ↗
• MalfunctionApr 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER. IT WAS REPORTED THAT THE AT THE TIME OF INJECTION, THE EXTENSION SET STARTED LEAKING AT THE CONNECTION END DURING SALINE FLUSH. THERE WAS PATIENT INVOLVEMENT BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858679 ↗
• MalfunctionMar 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT WHILE COMPLETING IV STARTS ON PATIENT, THE STAFF NOTED THAT SEVERAL PATIENT IV EXTENSION LINES WERE LEAKING. THAT WAS A MAJOR PROBLEM, AS ALL PATIENTS IN PET/CT DEPARTMENT AND MOST IN THE NUCLEAR MEDICINE DEPARTMENTS NEED THE LINES WHEN INJECTING A RADIOACTIVE PHARMACEUTICAL. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678476 ↗
• MalfunctionMar 3, 2025Material Separation; Material Separation

  THE EVENT INVOLVED A 7" (18 CM) APPX 0.24 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER WHERE IT WAS REPORTED AN IV WAS INSERTED AND EXTENSION TUBING ATTACHED TO CATHETER. AS SOON AS THEY TRIED TO FLUSH THE EXTENSION TUBING AT THE SITE OF THE LUER LOCK POPPED OFF, WITH ASSISTANCE FROM THEIR COLLEAGUE THEY WERE ABLE TO ATTACH ANOTHER EXTENSION SET AND THE IV WAS STILL WORKING. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21511408 ↗
• MalfunctionDec 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT REGARDING A SMALLBORE PRESSURE INFUSION EXTENSION SET W/MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER EXPERIENCED LEAKAGE. IT WAS REPORTED BY THE INITIAL REPORTER "THERE WAS SLIGHT LEAKAGE OF SALINE FLUSH AND RADIOACTIVE TRACER OCCURRED AT THE WIDEST PART OF THE HARD PLASTIC BARREL SEGMENT OF THE NEEDLESS CONNECTOR ON AN INTRAVENOUS EXTENSION SET. STILL HAND-INJECTING BUT WITH REDUCED PRESSURE, LEAKAGE COULD BE AVOIDED, AND THE MEDICATION WAS ADMINISTERED WITH MINIMAL TOTAL LEAKAGE/CONTAMINATION. NO CHANGE IN CLINICAL OUTCOME. PATIENT WAS ABLE TO COMPLETE SCAN, AND IMAGES WERE ACQUIRED WITHOUT ISSUE THANKS TO CONTAMINATION PADS SET UP AHEAD OF INJECTION AND DISPOSED OF APPROPRIATELY. " THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21023623 ↗
• MalfunctionNov 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED WITH REGARDS TO A 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER THAT EXPERIENCED LEAKAGE. THE REPORTER STATED THAT MC33098 (4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 3 CLAMPS, ROTATING LUER) WAS CONNECTED TO MC33150. THEN DURING INFUSION, THE MC33098 GOT DISCONNECTED TO MC33150 AND RESULTED IN LEAKING. THE EVENT DATE WAS UNKNOWN. IT WAS ALSO STATED THAT THEY DID NOT RETAIN THE SAMPLE OF MC33150. THE EVENT OCCURRED WHILE THE PRODUCT WAS IN USE WITH A PATIENT. THERE WAS NO HUMAN HARM REPORTED TO BE ASSOCIATED WITH THE EVENT. THUS, THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM AND UNKNOWN DELAY IN THERAPY. THE LOT NUMBER OF THE SAMPLE AFFECTED WAS NOT RETAINED. THERE WAS A SLIGHT DELAY IN THERAPY SINCE THEY NEEDED TO REPLACE THE IMPACTED PRODUCTS WITH NEW. THE LEAKING WAS LOCATED FROM THE END OF THE MC33098. WHEN IT DISCONNECTED FROM MC33150, THE INFUSION CONTINUED AND LEAKED AT THE DISCONNECTION POINT. ONLY MC33098 IS AVAILABLE TO RETURN FOR TESTING. MC33150 IS STILL ON THE PATIENT¿S LINE AND DOES NOT SEEM TO BE HAVING ANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20767058 ↗
• MalfunctionNov 21, 2024No Flow; No Flow

  A COMPLAINT WAS RECEIVED REGARDING A 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER THAT EXPERIENCED NO FLOW. IT WAS STATED IN THE REPORT THAT THE PATIENT WAS A RESEARCH PATIENT THEREFORE UNSURE OF EXACT DOSE GIVEN/ >80%. THE EVENT OCCURRED ON (B)(6) 2024. THE SAMPLE WAS AVAILABLE FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENT REPORTED. IT WAS FURTHER STATED THAT THE DEVICE FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747999 ↗
• MalfunctionAug 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER. IT WAS REPORTED THAT THERE WAS LEAKING FROM PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WHERE J-LOOP IS CONNECTED TO THE CLAVE. IT WAS ALSO NOTED THAT THE RN NOTICES WET SPOT ON THE INFANT¿S BED & MOVED THE INFANT-TO-INFANT SEAT TO CLEAN THE SHEETS OF THAT THE RN THOUGHT WAS SPILLED STERILE WATER FROM GT CLEANING, AND AFTER THIS THE RN CHECKED ON THE INFANT AND NOTICED THAT THE SEAT WAS ALSO WET WITH CLEAR FLUID. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM, NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077778 ↗
• MalfunctionJul 10, 2024Crack; Crack

  THE EVENT INVOLVED A 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT THERE WAS A CRACK ON THE J-LOOP. THERE WAS PATIENT INVOLVEMENT, AND NO HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19709478 ↗
• MalfunctionJun 16, 2024Fluid/Blood Leak; Incomplete or Inadequate Connection; Fluid/Blood Leak; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER GENERATED A LEAK DURING PATIENT USE. IT WAS REPORTED BY THEIR STOREROOM INVENTORY COORDINATOR THAT THE SET EXTENSIONS WERE DEFECTIVE. THE INTRAVENOUS (IV) SET EXTENSIONS ARE LEAKING AT THE CONNECTION TO THE IV SET. THE ITEM IS ALSO NOT SCREWING ON CORRECTLY TO THE NEEDLES. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19544605 ↗
• MalfunctionJun 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP THAT WAS REPORTEDLY LEAKING AT THE CONNECTION TO THE INTRAVENOUS (IV) SET. THE DEVICE WAS ALSO NOT PROPERLY SCREWING ONTO UNSPECIFIED NEEDLES. THERE WAS UNKNOWN PATIENT INVOLVEMENT, NO INJURY OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19455254 ↗

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-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-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