ICU Medical 42801-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00887709120655), received between Dec 19, 2023 and May 16, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “No Flow” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K052828); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Inaccurate Delivery; Inaccurate Delivery

  THE EVENT INVOLVED A TRANSPAC¿ IT MONITORING KIT, 60" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MACRODRIP WHERE IT WAS REPORTED THAT IN CCU, RN ARRIVED FOR SHIFT AND RECEIVED IN HAND OFF THAT ARTERIAL LINE HAD BEEN HAVING ISSUES DAMPENING AND GOING FLAT BUT WOULD RESOLVE WITH A FLUSH. AROUND 21:00 THE PUMP HAD ALARMED SEVERAL TIMES FOR INCREASING PRESSURE, SO RN MADE THE DECISION TO CHANGE OUT THE TRANSDUCER. AFTER CHANGING OUT THE TRANSDUCER THE ARTERIAL LINE CONTINUED HAVING ISSUES WITH DAMPENING AND AGAIN STARTED TO ALARM FOR INCREASING PRESSURE. AROUND 2240 RN CHANGED TRANSDUCER AGAIN TO NICU TRANSDUCER. AFTER CHANGING THE TRANSDUCER, A SECOND TIME THE LINE WAS COMPLETELY FLAT AND WAS INITIALLY READING THE PATIENT'S MAP. SHORTLY AFTER THE PRESSURE BEGAN TO RISE ALL THE WAY TO THE 200S. RN CALLED INTENSIVIST TO RE-WIRE LINE. LINE WAS ABLE TO BE SALVAGED BUT REQUIRED A NEW DRESSING. THE EVENT DATE OCCURRED DURING INFUSION. THE TUBING WAS REPLACED. ARTERIAL LINE FLUIDS WERE USED. THERE WAS NO HOLE, CUT, TEARS, ANY CRACK, DISCONNECTION OR SEPARATION NOTED. NO LOT NUMBER PROVIDED AS THE PACKAGING WAS ALREADY DISCARDED BUT SAMPLE IS AVAILABLE FOR EVALUATION. THERE WAS PATIENT INVO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040870 ↗
• MalfunctionMay 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE COMPLAINT/EVENT INVOLVED A TRANSPAC¿ IT MONITORING KIT, 60" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MACRODRIP. THE REPORTER STATED THAT, IN THE CCU, THEY ENCOUNTERED A DAMPENED WAVEFORM, A HIGH READING, AND/OR CONSTANT INCREASING PRESSURE ALARMS DURING AN PATIENT'S INFUSION OF FLUIDS. THE TUBING WAS REPLACED. THERE WAS NO HOLE, CUT, TEARS, ANY CRACK, DISCONNECTION OR SEPARATION NOTED. THERE WAS NO HUMAN HARM AND NO DELAY IN THERAPY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22030545 ↗
• MalfunctionMay 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE COMPLAINT/EVENT INVOLVED A TRANSPAC¿ IT MONITORING KIT, 60" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MACRODRIP. THE REPORTER STATED THAT, IN THE PICU, THE PATIENT'S ARTERIAL LINE WAS NOT CONSISTENTLY MEASURING AND WOULD FREQUENTLY FLATTEN OR DAMPEN ON THE PATIENT'S MONITOR DURING AN INFUSION OF FLUIDS. THIS PREVENTED STAFF FROM OBTAINING ACCURATE ARTERIAL BLOOD PRESSURE (ABP) READINGS ON A PATIENT WHO WAS ON CONTINUOUS ANTIHYPERTENSIVE MEDICATION AT THE TIME. THE TRANSDUCER WAS ORIGINALLY ON A SYRINGE PUMP BUT WAS SWITCHED OVER TO A PRESSURE BAG OVERNIGHT DUE TO PRESSURE ALARMING/PUMP ISSUES. THE ARTERIAL LINE CONTINUED TO HAVE ISSUES AFTER SWITCHING TO A PRESSURE BAG. THE TUBING WAS REPLACED. THERE WAS NO HOLE, CUT, TEARS, ANY CRACK, DISCONNECTION OR SEPARATION NOTED. THERE WAS NO HUMAN HARM AND NO DELAY IN THERAPY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22030207 ↗
• MalfunctionMay 15, 2025No Flow; No Flow

  THE COMPLAINT/EVENT INVOLVED A TRANSPAC¿ IT MONITORING KIT, 60" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MACRODRIP. THE PATIENT'S ART LINE REPORTEDLY ALARMED FOR INCREASING PRESSURE AND THE TRANSDUCER HAD TO BE CHANGED OUT DURING A PATIENT'S INFUSION ON UNSPECIFIED FLUIDS IN THE CRITICAL CARE UNIT. THERE WAS NO HOLE, CUT, TEARS, ANY CRACK, DISCONNECTION OR SEPARATION NOTED. THERE WAS NO HUMAN HARM AND NO DELAY IN THERAPY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027379 ↗
• MalfunctionFeb 19, 2025No Flow; No Flow

  THE EVENT INVOLVED A TRANSPAC¿ IT MONITORING KIT, 60" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MACRODRIP WHERE THE REPORTER STATED THAT THE ART LINE WHICH CAME FROM THE OPERATING ROOM (OR), CONTINUED HAVING HIGH PRESSURE ALARMS AND OCCLUSION ALERTS REGARDLESS OF TROUBLESHOOTING. PATIENT WAVEFORM ALSO DAMPENED. 50 ML SYRINGE, 3 ML/HR, NO OTHER DISCERNABLE LINE ISSUES, FLUSHED AND DREW BLOOD WELL. THE DRESSING CHANGED WITH LITTLE TO NO IMPROVEMENT. TRANSDUCER CHANGED AND PROBLEM RESOLVED. THE EVENT OCCURRED DURING IN USE FOR PATIENT INFUSION. THUS, THERE WAS PATIENT INVOLVEMENT, UNKNOWN HUMAN HARM AND UNKNOWN DELAY IN THERAPY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415075 ↗
• MalfunctionJan 29, 2025High Readings; High Readings

  THE EVENT INVOLVED A TRANSPAC¿ IT MONITORING KIT, 60" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MICRODRIP. THE REPORTER STATED THAT THERE HAS BEEN INACCURATELY HIGH BLOOD PRESSURE READINGS AND HIGH-PRESSURE ALARMS CARDIAC CARE UNIT ROOM 2004. THERE WAS PATIENT INVOLVEMENT, UNKNOWN HUMAN HARM AND UNKNOWN DELAY IN THERAPY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21263657 ↗
• MalfunctionJan 14, 2025No Flow; No Flow

  THE EVENT INVOLVED A TRANSPAC¿ IT MONITORING KIT, 60" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MACRODRIP. THE REPORTER STATED THAT THEY HAD SEVERAL INSTANCES OF INCREASING PRESSURE ALARMS WHICH MEANS THAT THE FLUID WAS NOT INFUSING PROPERLY THROUGH THE TRANSDUCER. IT WAS ALSO STATED THAT THE INCREASING PRESSURE ALARMS WERE RESOLVED AFTER PULLING THE ¿BLUE TAB¿ ON THE TRANSDUCER, WHICH MAKES THE FLUID UNABLE TO PASS THROUGH THE TRANSDUCER PROPERLY. THE FLUID THAT USED WAS AN ARTERIAL LINE FLUID. IT WAS ALSO STATED THAT ALL OF THESE TRANSDUCERS WERE UTILIZING ARTERIAL LINE FLUID RUNNING AT 1-2 ML/HR ON A SYRINGE PUMP. ALL OF THESE HAD 30ML SYRINGES RUNNING ON MEDFUSION 4000 SYRINGE PUMPS. THE PRESSURE BAR ON THE SYRINGE PUMP WILL DECREASE IF THE BLUE TAB ON THE TRANSDUCER IS PULLED WHICH IS WHY THEIR CLINICIANS THOUGHT THAT IT HAS SOMETHING TO DO WITH THE FLUID MOVING THROUGH THE TRANSDUCER. THIS SEEMS TO BE OCCURRING ON NIGHT 2-3 OF THE TRANSDUCER BEING USED AND SWITCHED OUT EVERY 4 DAYS/ 96 HOURS. THEY ATTACH THEIR TRANSDUCERS TO KIDS' KITS, BUT THIS IS NOT A RECENT CHANGE IN PRACTICE. HENCE, THERE WAS NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21154570 ↗
• MalfunctionJan 14, 2025No Flow; No Flow

  THE EVENT INVOLVED A TRANSPAC¿ IT MONITORING KIT, 60" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MACRODRIP. THE REPORTER STATED THAT THEY HAD SEVERAL INSTANCES OF INCREASING PRESSURE ALARMS WHICH MEANS THAT THE FLUID WAS NOT INFUSING PROPERLY THROUGH THE TRANSDUCER. IT WAS ALSO STATED THAT THE INCREASE PRESSURE ALARMS WERE RESOLVED AFTER PULLING THE ¿BLUE TAB¿ ON THE TRANSDUCER, WHICH MAKES THE FLUID UNABLE TO PASS THROUGH THE TRANSDUCER PROPERLY. STATUS WAS DURING INFUSION. THE FLUID THAT USED WAS ARTERIAL LINE FLUID. IT WAS ALSO STATED THAT ALL OF THESE TRANSDUCERS WERE UTILIZING ARTERIAL LINE FLUID RUNNING AT 1-2 ML/HR ON A SYRINGE PUMP. ALL OF THESE HAD 30ML SYRINGES RUNNING ON MEDFUSION 4000 SYRINGE PUMPS. THE PRESSURE BAR ON THE SYRINGE PUMP WILL DECREASE IF THE BLUE TAB ON THE TRANSDUCER IS PULLED WHICH IS WHY THEIR CLINICIANS THOUGHT THAT IT HAS SOMETHING TO DO WITH THE FLUID MOVING THROUGH THE TRANSDUCER. THIS SEEMS TO BE OCCURRING ON NIGHT 2-3 OF THE TRANSDUCER BEING USED AND SWITCHED OUT EVERY 4 DAYS/ 96 HOURS. THEY ATTACH THEIR TRANSDUCERS TO KIDS KITS, BUT THIS IS NOT A RECENT CHANGE IN PRACTICE. HENCE, THERE WAS NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148992 ↗
• MalfunctionJan 14, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE EVENT OCCURRED ON VARIOUS DAYS IN (B)(6) 2024 AND INVOLVED A TRANSPAC¿ IT MONITORING KIT, 60" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MACRODRIP. THE REPORTER STATED THAT THEY HAD A COUPLE ARTERIAL LINES THAT WERE SIGNIFICANTLY DAMPENED. IT WAS ALSO STATED THAT IT REQUIRED INTERVENTIONS (REWIRING) FOR BOTH OF THESE ARTERIAL LINES THAT HAD ISSUES WITH TRANSDUCERS. THESE REPORTED TRANSDUCERS WERE CHANGED ON (B)(6) 2024 AND ALSO CHANGED TWO TRANSDUCERS TODAY THAT WERE HAVING ISSUES. IT WAS ALSO STATED THAT ALL OF THESE TRANSDUCERS WERE UTILIZING ARTERIAL LINE FLUID RUNNING AT 1-2 ML/HR ON A SYRINGE PUMP. ALL OF THESE HAD 30ML SYRINGES RUNNING ON MEDFUSION 4000 SYRINGE PUMPS. THE PRESSURE BAR ON THE SYRINGE PUMP WILL DECREASE IF THE BLUE TAB ON THE TRANSDUCER IS PULLED WHICH IS WHY THEIR CLINICIANS THOUGHT THAT IT HAS SOMETHING TO DO WITH THE FLUID MOVING THROUGH THE TRANSDUCER. THIS SEEMS TO BE OCCURRING ON NIGHT 2-3 OF THE TRANSDUCER BEING USED AND SWITCHED OUT EVERY 4 DAYS/ 96 HOURS. THEY ATTACH THEIR TRANSDUCERS TO KID'S KITS, BUT THIS IS NOT A RECENT CHANGE IN PRACTICE. HENCE, THERE WAS NO HUMAN HARM REPORTED. THIS CAPTURES 2 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148982 ↗
• MalfunctionDec 19, 2023Unable to Obtain Readings; High Readings; Unable to Obtain Readings; High Readings

  THE EVENT INVOLVED A TRANSPAC¿ IT MONITORING KIT, 60" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MACRODRIP WHERE IT WAS REPORTED THE PRODUCT WAS BEING USED TO TRANSDUCE AN ARTERIAL LINE PRESSURE FOR A PATIENT AND WAS INITIALLY PROVIDING A READING, THEN FOR NO APPARENT REASON STOPPED PROVIDING A READING. THEY TROUBLESHOT THE LINE, RE-ZEROED, CHECKED THE CATHETER, BUT WERE UNABLE TO PRODUCE ANY VALUES. THEY THEN WERE ABLE TO SUCCESSFULLY USE A DIFFERENT SET OF TUBING TO OBTAIN A READING. THERE WAS NO ADVERSE EVENT, AND NO ONE WAS HARMED AS A RESULT OF THE REPORTED EVENT. INVESTIGATION WAS COMPLETED, THE TRANSPAC WAS ELECTRICALLY TESTED, AND A WAVE FORM WAS ABLE TO BE ZEROED WITH THE WAVEFORM BEYOND THE SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357829 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052828. One submission often covers many models, so check the product and lot details in each record.

• Z-1071-2019 · Nov 27, 2018 · Terminated
  ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06