ICU Medical 46104-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00887709060623), received between Jul 12, 2023 and Jul 23, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

193 other recalls cover devices cleared under the same FDA submission (K061573); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2024Disconnection; Material Separation; Disconnection; Material Separation

  GCM RECEIVED AN EMAIL ON 24-MAY-2024 FROM ICU MEDICAL CRITICAL CARE SPECIALIST FORWARDING A COMPLAINT FROM (B)(6) A CLINICAL VALUE ANALYST OF (B)(6) HOSPITAL REGARDING A MONITORING KIT W/TP4, 30 ML SQUEEZE FLUSH AND NEEDLELESS VALVE WITH ITEM NUMBER 46104 AND LOT NUMBER 11376856. IT WAS STATED IN THE REPORT THAT WHEN PRIMING NEONATAL A-LINE TRANSDUCER, THE STOPCOCK AT THE END OF THE TRANSDUCER LINE CAME APART AND FELL BACK ONTO STERILE FIELD, THE TUBING CAME APART FROM THE STOPCOCK. DEVICE WAS NOT REPROCESSED AND REUSED ON A NEWBORN MALE PATIENT. THE EVENT OCCURRED ON 09-MAY-2024 DURING PRIMING. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. RMONTES 27-MAY-2024UPDATE: GCM RECEIVED AN EMAIL ON 29-MAY-2024 FROM (B)(6) STATING THAT THERE WAS NO MEDICATION INVOLVED, NO PATIENT HARM AND NO DELAY IN THERAPY. RMONTES 29-MAY-2024

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19813224 ↗
• MalfunctionJun 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A MONITORING KIT W/TP4, 30 ML SQUEEZE FLUSH AND NEEDLELESS VALVE WHERE THE CUSTOMER REPORTED THAT WHEN FLUSHING THE PATIENT'S ARTERIAL LINE AFTER A LAB DRAW, BLOOD/FLUIDS EXPELLED THROUGH PORT ON STOPCOCK USED TO SAMPLE BLOOD. THE EVENT OCCURRED DURING INFUSION BUT THERE WAS NO PATIENT HARM BUT THERE WAS A DELAY ON THERAPY DURING ADDITIONAL REQUIRED LINE CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601793 ↗
• MalfunctionJun 23, 2024Disconnection; Material Separation; Disconnection; Material Separation

  THE EVENT INVOLVED A MONITORING KIT W/TP4, 30 ML SQUEEZE FLUSH AND NEEDLELESS VALVE IT WAS STATED IN THE REPORT THAT WHEN PRIMING NEONATAL A-LINE TRANSDUCER, THE STOPCOCK AT THE END OF THE TRANSDUCER LINE CAME APART AND FELL BACK ONTO STERILE FIELD, THE TUBING CAME APART FROM THE STOPCOCK. DEVICE WAS NOT REPROCESSED AND REUSED ON A NEWBORN MALE PATIENT. THE EVENT OCCURRED ON (B)(6) 2024 DURING PRIMING. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591731 ↗
• MalfunctionJun 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A MONITORING KIT W/TP4, 30 ML SQUEEZE FLUSH AND NEEDLELESS VALVE WHERE THE CUSTOMER REPORTED THAT BLOOD SAMPLE DRAW STOPCOCK ON ARTERIAL LINE SETUP LEAKING WHEN FLUSHED THROUGH. THE CONNECTION WAS TIGHTENED AND WAS ABLE TO FLUSH THROUGH WITHOUT LEAKING. LEAKING OCCURRED AGAIN AROUND 2200 WHEN FLUSHING THROUGH, AND CONNECTIONS WERE TIGHT. THERE WAS NO LEAKING UNLESS FLUSHING THROUGH LINE. LINE WAS ALSO DIFFICULT TO FLUSH. THE CUSTOMER ORDERED A NEW A-LINE FLUID BAG AND WAS ABLE TO CHANGE OVER SETUP AT 0300. ONCE SETUP WAS CHANGED, THERE WERE NO ISSUES WITH FLUSHING/DRAWING OR LEAKING. THE CUSTOMER STATED THAT THE DEVICE WAS NOT REPROCESSED AND REUSED ON A 3-WEEK FEMALE PATIENT. THE EVENT OCCURRED ON 22-MAY-2024. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THE CUSTOMER STATED THAT THERE WAS NO MEDICATION INVOLVED AND NO DELAY IN THERAPY. NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19580162 ↗
• MalfunctionSep 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A MONITORING KIT W/TP4, 30 ML SQUEEZE FLUSH, AND NEEDLELESS VALVE WAS FOUND BROKEN WITHIN MINUTES OF ATTACHING THE NEW LINE TO THE PATIENT'S UMBILICAL ARTERY CATHETER (UAC), AND THE REGISTERED NURSE (RN) NOTICED BACKFLOW OF BLOOD THROUGH UAC. IMMEDIATELY NOTED THAT THE TUBING HAD BROKEN ON THE DISTAL SIDE OF THE BLOOD DRAW PORT. UAC WAS IMMEDIATELY CLAMPED. THE BROKEN TRANSDUCER WAS DISCONNECTED AND UAC FLUSHED WITH NORMAL SALINE. NEW TUBING WAS PRIMED AND ATTACHED TO THE PATIENT'S UAC. THE BROKEN TRANSDUCER WAS BAGGED AND KEPT IN THE C4B CLINICAL LEADER'S OFFICE. TO NOTE, THIS IS A C4B PATIENT CURRENTLY ON H4B FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). C4B CHARGE RN AND ECMO TECH NOTIFIED OF EQUIPMENT ISSUE. THERE WAS NO MEDICATION BEING USED WITH THE PRODUCT AND THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17831485 ↗
• MalfunctionAug 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A MONITORING KIT W/TP4, 30 ML SQUEEZE FLUSH AND NEEDLELESS VALVE IN WHICH THE CUSTOMER REPORTED THAT THE NURSE WAS HANGING NEW FLUIDS FOR THE PATIENT'S ARTERIAL LINE, AND WHEN THE NURSE HOOKED UP THE NEW FLUIDS TO THE PATIENT, THE NURSE NOTICED BLOOD BACKING UP IN THE LINE. UPON FURTHER INSPECTION IT WAS NOTICED THAT THE TUBING WAS BROKEN AT THE TUBING/LUER CONNECTION. ONCE THE NURSE NOTICED BLOOD BACKING UP, THE STOP COCK CLOSEST TO THE INFANT WAS IMMEDIATELY TURNED OFF TO BABY AND THE PRACTITIONER WAS CALLED. THE NEW LINE WAS HUNG AND WORKING PROPERLY AT THIS TIME. THE CUSTOMER REPORTED THAT THE PRODUCT WAS NOT REPROCESSED NOR RE-STERILIZED PRIOR TO USE AND THAT IS IS NOT CONTAMINATED OR CONTAIN BIOHAZARD OR CHEMOTHERAPEUTIC AGENT. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595579 ↗
• MalfunctionJul 12, 2023Break; Break

  THE INCIDENT INVOLVED A MONITORING KIT W/TP4, 30 ML SQUEEZE FLUSH AND NEEDLELESS VALVE. IT WAS REPORTED THAT THE PRESSURE TUBING BROKE IN HALF. IT WAS MENTIONED THAT THE REGISTERED NURSE WAS HAVING DIFFICULTY GETTING AN ARTERIAL WAVEFORM ON THE BEDSIDE MONITOR SO THEY CHECKED THE SET AND NOTICED THE BROKEN TUBING. THE MATING DEVICE WAS AN ALARIS INFUSION AND THE INFUSION WAS 0.9 NORMAL SALINE (NS). THE EVENT HAPPENED DURING INFUSION. THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17305340 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061573. One submission often covers many models, so check the product and lot details in each record.

• Z-0573-2017 · Sep 27, 2016 · Terminated
  Expression MR IBP DPT Kit, I/N, Box 20, Item No. 989803194641 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces be
• Z-0504-2017 · Sep 27, 2016 · Terminated
  ARTERIAL PRESSURE KIT W/03ML FLUSH DEVICE FOR LEBONHEUR CHILDRENS HOSP., Item No. 46091-31 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure
• Z-0427-2017 · Sep 27, 2016 · Terminated
  Transpac IV Monitoring Kit, 60", Disposable Transducer, 3 ml Squeeze Flush Device, Macrodrip, Item No. 42584-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an ex
• Z-0415-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. 011-42584-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascu
• Z-0507-2017 · Sep 27, 2016 · Terminated
  CATH LAB KIT FOR SALINA REGIONAL, Item No. 46092-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a ca
• Z-0478-2017 · Sep 27, 2016 · Terminated
  PERFUSION PUMP KIT FOR MEMORIAL HOSP., Item No. 46070-79 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between
• Z-0518-2017 · Sep 27, 2016 · Terminated
  CARDIAC CATH LAB KIT FOR PRESBYTERIAN INTERCOMMUNITY HOSP., Item No. 46095-33 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer th
• Z-0560-2017 · Sep 27, 2016 · Terminated
  Transpac IV Trifurcated Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset" Reservoir and Needleless Valves, Item No. 46112-05 The Transpac Disposable Straight Pressure
• Z-0508-2017 · Sep 27, 2016 · Terminated
  PEDIATRIC CVL MONITORING KIT W/03ML FLUSH DEVICE FOR YALE NEW HAVEN HOSP., Item No. 46094-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressur
• Z-0565-2017 · Sep 27, 2016 · Terminated
  Transpac IV Trifurcated Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush Device, Needleless Valves, Red, Blue and Yellow Stripe TBG, Item No. 46113-88 The Transpac Disp
• Z-0485-2017 · Sep 27, 2016 · Terminated
  Double LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-26 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduce
• Z-0430-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (INFUSION PUMP), Item No. 42586-05 The Transpac Disposable Straight Pressure Transducer (DSPT)
• Z-0477-2017 · Sep 27, 2016 · Terminated
  KIT W/30ML FLUSH DEVICE FOR ALL CHILDRENS Hospital, Item No. 46070-30 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that inter
• Z-0472-2017 · Sep 27, 2016 · Terminated
  RIGHT HEART KIT FOR NC BAPTIST HOSPITAL, Item No. 46066-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betwe
• Z-0552-2017 · Sep 27, 2016 · Terminated
  Transpac IV Monitoring Kit, 60", Disposable Transducer, 30 ML Intraflo Flush, Pall Air Filter, Macrodrip (Pole Mount), Item No. 46104-63 The Transpac Disposable Straight Pressure T

…and 178 more.