TranspacRecalls & reported problems across all models

We found 11 models of Transpac by Icu Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Jul 13, 2017 and Aug 3, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Transpac problems

Transpac models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Transpac™ 46115-10

  Transducer, blood-pressure, extravascular
  10 reports
• Transpac™ 460990471

  Transducer, blood-pressure, extravascular
  6 reports
• Transpac™ 46114-31

  Transducer, blood-pressure, extravascular
  5 reports
• Transpac™ 46103-68

  Transducer, blood-pressure, extravascular
  4 reports
• Transpac™ 46104-65

  Transducer, blood-pressure, extravascular
  4 reports
• Transpac™ 46109-86

  Transducer, blood-pressure, extravascular
  2 reports
• Transpac™ 46112-05

  Transducer, blood-pressure, extravascular
  2 reports
• Transpac 42587-05

  Catheter, continuous flush
  1 report
• Transpac™ 460990410

  Transducer, blood-pressure, extravascular
  1 report
• Transpac™ 46106-91

  Transducer, blood-pressure, extravascular
  1 report
• Transpac™ 46112-10

  Transducer, blood-pressure, extravascular
  1 report

Recent Transpac adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Fluid/Blood Leak; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50112770 ↗
• MalfunctionAug 27, 2025Crack; Crack

  EVENT OCCURRED REGARDING A MONITORING KIT W/ SAFESET¿ II, 03 ML FLUSH DEVICE & MARVELOUS VALVE WHERE IT WAS STATED IN THE REPORT "THAT A-LINE TUBING BROKE OFF IN TUBING.". THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903740 ↗
• MalfunctionAug 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A MEDWATCH WAS RECEIVED REGARDING A MONITORING KIT W/SAFESET¿ II, 03 ML FLUSH DEVICE & MARVELOUS VALVE THAT EXPERIENCED LEAKAGE DURING USE. IT WAS REPORTED THAT "PATIENT HAD R [RIGHT] ULNAR A-LINE [ARTERIAL LINE]. TUBING NOT DUE UNTIL TOMORROW NIGHT. GRABBING BLOOD TO SEND DOWN A LACTIC ACID. BLOOD DRAWN. AS PUSHING THROUGH "WASTED" BLOOD THROUGH SAFESET, BALLOON IN SYRINGE POPS. BLOOD LEAKS QUICKLY OUT OF SYRINGE FROM A-LINE. LINE CLAMPED. TUBING CHANGED." ADDITIONAL EVENT INFORMATION OBTAINED FROM UFMW: THIS IS NOT A LABORATORY DEVICE OR LABORATORY TEST. THE LOCATION WHERE EVENT OCCURRED WAS IN HOSPITAL¿S CRITICAL CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22812661 ↗
• MalfunctionJun 11, 2025Crack; Crack

  IT WAS REPORTED THAT WITH REGARDS TO A TRANSPAC® IV MONITORING KIT, 60", 03 ML SQUEEZE FLUSH DEVICE, 2 3 WAY STOPCOCKS AND MACRODRIP THAT THE SPIKE BROKE AT THE SET RIGHT AT THE BAG. THE REGISTERED NURSE WAS RELEASING PRESSURE ON THE IV FLUID/PRESSURE BAG TO CHANGE THE IV FLUID BAG WHEN SHE RECOGNIZED THAT THE SPIKE HAD SNAPPED OFF AND WAS INSIDE THE IV FLUID BAG. THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184143 ↗
• MalfunctionMay 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A TRANSPAC® IV KIT W/03 ML SQUEEZE FLUSH DEVICE, PT TUBINGS, 3 3-WAY STOPCOCKS AND 36" ADMIN SET. LEAKS OF AN UNSPECIFIED FLUID WERE REPORTED IN THE TUBING BETWEEN #1 AND STOPCOCK #2 (FLUID LEAKING OUT) DURING PATIENT USE. THERE WAS NO ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022467 ↗
• MalfunctionMay 14, 2025Difficult to Flush; Difficult to Flush

  THE COMPLAINT/EVENT INVOLVED A TRANSPAC® IV KIT W/03 ML SQUEEZE FLUSH DEVICE, PT TUBINGS, 3 3-WAY STOPCOCKS AND 36" ADMIN SET. THE LINES REPORTEDLY COULD NOT BE FLUSHED THROUGH DURING USE ON A PATIENT. THERE WAS NO ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022256 ↗
• MalfunctionMay 14, 2025Leak/Splash; Leak/Splash

  THE COMPLAINT/EVENT INVOLVED A TRANSPAC® IV KIT W/03 ML SQUEEZE FLUSH DEVICE, PT TUBINGS, 3 3-WAY STOPCOCKS AND 36" ADMIN SET. LEAKS WERE REPORTED IN THE TUBING OF THE DEVICE DURING USE ON A PATIENT. THE LOCATION OF THE LEAK WAS NEAR THE SMALL HOLE (AND UNSPECIFIED FLUID WAS SHOOTING OUT OF THAT HOLE). THERE WAS NO ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021978 ↗
• MalfunctionMay 7, 2025No Flow; No Flow

  THE EVENT INVOLVED ATRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH AND MACRODRIP WHERE THE CUSTOMER REPORTED THAT THEIR NICU HAS BEEN EXPERIENCING ISSUES WITH ARTERIAL LINE OCCLUSION ALARMS ON THEIR BD ALARIS PUMPS WHEN USING THE TRANSPAC KIT. THE INFUSION RATE IS TYPICALLY SET AT 1 ML/HR. THE CUSTOMER STATED THAT THEIR TROUBLESHOOTING HAS BEEN UNSUCCESSFUL THE MAJORITY OF THE TIME AND THEY'VE ONLY BEEN SUCCESSFUL CORRECTING THE ISSUE WHEN THE CAPS ARE CHANGED ON THE TRANSPAC. THE MAJORITY OF THE TIME IT IS NOT SUCCESSFUL, AND THEY HAVE TO CHANGE OUT THE SET. THE INCIDENT OCCURRED DURING PATIENT USE; NO MEDICATION WAS BEING USED WITH THE DEVICE. HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21980302 ↗
• MalfunctionMay 5, 2025Crack; Fluid/Blood Leak; Leak/Splash; Crack; Fluid/Blood Leak; Leak/Splash

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TRANSPAC® IV KIT W/35" PT, 6" PT AND 3 NEEDLELESS VALVES. THE CUSTOMER REPORTED THAT THE DEVICE WAS NOTED TO BE CRACKED WITH IV FLUID SPRAYING OUT OF IT. THE DEVICE WAS USED ON A PATIENT, HOWEVER, THERE WAS NO HARM REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21964652 ↗
• MalfunctionMay 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TRANSPAC® IV KIT W/35" PT, 6" PT AND 3 NEEDLELESS VALVES WHERE THE CUSTOMER REPORTED THAT THE DEVICE HAD IV FLUID SPRAYING OUT OF IT. THE CUSTOMER WAS UNAWARE WHETHER OR NOT THERE WAS A CRACK. 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 21964550 ↗
• MalfunctionApr 17, 2025No Flow; No Flow

  THE EVENT INVOLVED A TP4 KIT W/10CC SAFESET RESERVOIR, NEEDLELESS VALVE FILTER MILLEX AND ADMIN SET WHERE IT WAS REPORTED THE REGISTERED NURSE (RN) DREW LABS FROM THE A-LINE WITHOUT ISSUE; HOWEVER, WHEN HE ATTEMPTED TO FLUSH THE LINE, HE WAS UNABLE TO PULL ANY FLUSH FROM THE BAG. THE A-LINE STILL HAD A GOOD WAVEFORM AND BLOOD RETURN. THE LINE WAS CHANGED OUT AND THE OLD LINE WAS PLACED. THERE IS POTENTIAL PATIENT HARM WITH EXTRA LINE CHANGE AT RISK FOR CLABSI. THERE WERE NO OTHER DEVICES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859446 ↗
• MalfunctionNov 27, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  THE COMPLAINT/EVENT INVOLVED A MONITORING KIT W/SAFESET¿ II, 03 ML FLUSH DEVICE AND MARVELOUS VALVE. THE REPORT STATES THAT THE ARTERIAL LINE SYRINGE DID NOT CLIP INTO PLACE. IT APPEARED THAT THE WHITE DISC ABOVE THE SYRINGE IS LOOSE PREVENTING THE CLIPS TO SECURE INTO REST OF DEVICE. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800700 ↗
• MalfunctionNov 23, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED WITH REGARDS TO MONITORING KIT W/SAFESET II¿, 03 ML FLUSH DEVICE & MARVELOUS VALVE THAT EXPERIENCED LEAKAGE. THE REPORTER STATED THAT " A-LINE TUBING FAULTY, BLOOD SPEWING FROM SMALL HOLE ON SIDE PORT OF STOP-COCK. A-LINE REMOVED FROM PATIENT AND SEQUESTERED. THE EVENT DATE WAS ON 22-OCT-2024. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT. THE AMOUNT OF BLOOD LOSS WAS UNKNOWN. THEN THE CUSTOMER WAS ASKED ABOUT THE STATUS OF THE PRODUCT AT THE TIME OF EVENT SHE ANSWERED "WHEN CONNECTED TO TUBING, WITH BLOOD COMING OUT".

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20767006 ↗
• MalfunctionOct 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION REGARDING THIS COMPLAINT WAS RECEIVED AS FOLLOWS: A MEDSUN MEDWATCH UF/IMPORTER REPORT # (B)(4) WAS RECEIVED ON 27-NOV-2024 THAT STATED "ICU MEDICAL DEVICE A-LINE PRESSURE TUBING SET LEAKED WHEN RN PUT CONNECTED THE SET TO IVF IN A PRESSURE BAG. RN SET UP PRESSURE TUBING AND CONNECTED TO PATIENT AND NOTED THAT BLOOD WAS BACKFLOWING INTO THE SET. SHE THEN REALIZED THERE WAS A LEAK IN THE SYSTEM. SHE DISCONNECTED THE SET AND REPLACED IT WITH ANOTHER PRESSURE TUBING SET WHICH WORKED WITHOUT ISSUE. THE LEAK OCCURRED AT THE FLUSH CHAMBER JUST ABOVE WHERE FLUID WOULD ENTER THE CHAMBER." THIS ISSUE WAS ORIGINALLY REPORTED BY (B)(6), A NURSE OF (B)(6) HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359675 ↗
• MalfunctionApr 30, 2024Break; Material Separation; Break; Material Separation

  THE EVENT INVOLVED A TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, NEEDLELESS VALVE, 10 CC CONTAMINATION SHEATH SYRINGE AND ADMIN SET WHERE IT WAS REPORTED THAT DURING PATIENT USE, THAT THE ARTERIAL LINES BROKE WHILE IN USE. THERE WAS PATIENT INVOLVED AND HARM REPORTED BUT NO ADVERSE EVENT OR DEATH REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED ON THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19218485 ↗

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