ICU Medical 42801-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00887709120778), received between Jan 20, 2023 and May 16, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Disconnection” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML FLUSH DEVICE, UN-BONDED MACRODRIP WHERE THE CUSTOMER REPORTED THAT THE ARTERIAL LINE TUBING CAME DISCONNECTED/BROKE AT AN ACCESS PORT WHILE A PATIENT WAS BEING TURNED; THE PATIENT HAD MINIMAL BLOOD LOSS UNTIL ISSUE WAS RESOLVED. THE CUSTOMER WAS UNSURE IF TUBING GOT PULLED - THEY DID NOT NOTICE THAT THE TUBING BECAME DISCONNECTED UNTIL THE TURN WAS COMPLETE AND BLOOD WAS FOUND IN THE BED. THERE WAS PATIENT INVOLVEMENT BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22040490 ↗
• MalfunctionFeb 19, 2025Inaccurate Information; Inaccurate Information

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML FLUSH DEVICE, UN-BONDED MACRODRIP WHERE THE REPORTER STATED THAT THE ART LINE MALFUNCTIONED AND WAS REPORTING INCREASINGLY WORSENING HYPERTENSION, BUT WITH A GOOD WAVEFORM AND PERFECTLY FUNCTIONAL ART LINE TUBING/SET. THERE WAS PATIENT INVOLVEMENT BUT NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413703 ↗
• MalfunctionApr 23, 2024Break; Break

  THE EVENT INVOLVED A UNSPECIFIED TRANSPAC WITH SAFESET WHERE IT WAS REPORTED THAT THE SINGLE TRANSDUCER PRESSURE TUBING WAS CONNECTED TO AN ARTERIAL LINE, WHEN THE REGISTERED NURSE (RN) ATTEMPTED TO DRAW BACK ON THE VAMP TO DRAW BLOOD THE INTERNAL STRUCTURE OF THE VAMP SYRINGE BROKE. THE TUBING WAS REMOVED FROM USE AND A NEW SINGLE TRANSDUCER SET WAS UTILIZED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19167646 ↗
• MalfunctionAug 23, 2023Disconnection; Disconnection

  THE REPORTED COMPLAINT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML FLUSH DEVICE, UN-BONDED MACRODRIP. IT WAS REPORTED THAT THE A LINE TRANSDUCER CAME OFF OF THE BLUE CLIP. AN ATTEMPT TO PLACE IT BACK ON WAS UNSUCCESSFUL. THE A LINE WIRES THEN DETACHED FROM THE TRANSDUCER. THE ENTIRE A- LINE SET HAD TO BE REPLACED. THERE WERE NO INJURIES OR ADVERSE EVENT/HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17603104 ↗
• MalfunctionMar 14, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML FLUSH DEVICE, UN-BONDED MACRODRIP. IT WAS REPORTED THAT DURING USE ON A PATIENT THE RIGHT RADIAL ARTERIAL LINE TUBING DISCONNECTED FROM A FUSED POINT NEXT TO THE PLUNGER CAUSING ARTERIAL BLOOD TO BACK UP OUT OF THE ART LINE KIT, CRACKED OFF, BROKE COMPLETE APART FROM THE SUCTION PART OF THE SYRINGE AND ONTO THE FLOOR. THERE WAS PATIENT INVOLVEMENT AND DELAY IN THERAPY. THERE WAS NO PATIENT HARM. THIS IS THE SECOND OF TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16536838 ↗
• MalfunctionMar 14, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML FLUSH DEVICE, UN-BONDED MACRODRIP. IT WAS REPORTED THAT DURING USE ON A PATIENT THE RIGHT RADIAL ARTERIAL LINE TUBING DISCONNECTED FROM A FUSED POINT NEXT TO THE PLUNGER CAUSING ARTERIAL BLOOD TO BACK UP OUT OF THE ART LINE KIT, CRACKED OFF, BROKE COMPLETE APART FROM THE SUCTION PART OF THE SYRINGE AND ONTO THE FLOOR. THERE WAS PATIENT INVOLVEMENT AND DELAY IN THERAPY. THERE WAS NO PATIENT HARM. THIS IS THE FIRST OF TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16536827 ↗
• MalfunctionMar 14, 2023Disconnection; Disconnection

  THE INCIDENT INVOLVED A TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML FLUSH DEVICE, UN-BONDED MACRODRIP ON AN UNKNOWN DATE. IT WAS REPORTED THAT THERE WAS LEAKING NEAR THE TRANSDUCER. WHEN PULLING BACK THE PLUNGER ON THE ARTERIAL LINE KIT, IT CRACKED OFF AND BROKE COMPLETELY APART FROM THE SUCTION PART OF THE SYRINGE. THE CUSTOMER FURTHER REPORTED THAT THE RIGHT RADIAL ARTERIAL LINE TUBING DISCONNECTED FROM A FUSED POINT NEXT TO THE PLUNGER CAUSING ARTERIAL BLOOD TO BACK UP OUT OF THE LINE AND ONTO THE FLOOR. THE EVENT OCCURRED DURING USE ON PATIENT. THERE WAS DELAY IN THERAPY, BUT NO PATIENT HARM WAS REPORTED. THIS IS THE SECOND OF TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16536631 ↗
• MalfunctionMar 7, 2023Disconnection; Disconnection

  THE INCIDENT INVOLVED A TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML FLUSH DEVICE, UN-BONDED MACRODRIP ON AN UNKNOWN DATE. IT WAS REPORTED THAT THERE WAS LEAKING NEAR THE TRANSDUCER. WHEN PULLING BACK THE PLUNGER ON THE ARTERIAL LINE KIT, IT CRACKED OFF AND BROKE COMPLETELY APART FROM THE SUCTION PART OF THE SYRINGE. THE CUSTOMER FURTHER REPORTED THAT THE RIGHT RADIAL ARTERIAL LINE TUBING DISCONNECTED FROM A FUSED POINT NEXT TO THE PLUNGER CAUSING ARTERIAL BLOOD TO BACK UP OUT OF THE LINE AND ONTO THE FLOOR. THE EVENT OCCURRED DURING USE ON PATIENT. THERE WAS DELAY IN THERAPY, BUT NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16495649 ↗
• MalfunctionJan 20, 2023Disconnection; Disconnection

  THE EVENT INVOLVED A TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML FLUSH DEVICE, UN-BONDED MACRODRIP WHERE IT WAS REPORTED THAT THE ARTERIAL LINE BREAKS EASILY JUST DISTAL TO SAFE SET SYRINGE (TOWARDS PATIENT) SOON AFTER PRIMING PRIOR TO CONNECTING TO A PATIENT. IT WAS NOT SIMPLY A LUER LOCK DISCONNECT, WAS A BROKEN SECTION OF TUBING. THE SET UP WAS, THE DEVICE WAS CONNECTED TO A 500 ML NORMAL SALINE AND PRIMED. A PRESSURE BAG WAS UTILIZED WITH THE SALINE AFTER PRIMING AS IT WAS STANDARD PRACTICE FOR HEMODYNAMIC MONITORING. NO MEDICATIONS WERE INVOLVED. THERE WAS NO PATIENT INVOLVED AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16214885 ↗

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