ICU Medical 42800-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709097582), received between Jan 3, 2023 and Jun 22, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Readings” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2023Separation Problem; Separation Problem

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TRANSPAC¿ IT MONITORING KIT, 60" PRESSURE TUBING, 3ML FLUSH DEVICE, MACRODRIP, WHERE IT WAS REPORTED THAT THE KIT CAME APART AT THE TRANSDUCER CONNECTOR AND HAD TO BE REPLACED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17183749 ↗
• MalfunctionJan 3, 2023High Readings; High Readings

  THE EVENT INVOLVED A TRANSPAC¿ IT MONITORING KIT, 60" PRESSURE TUBING, 3ML FLUSH DEVICE, MACRODRIP. THE REPORTER STATED THAT THE TRANSDUCER LOOKED LIKE IT HAD A WRONG CALIBRATION WHEN IT WAS CALIBRATED CORRECTLY. THE DEVICE WAS READING A HIGH PRESSURE (280/170), BUT THE BLOOD PRESSURE CUFF ON THE PATIENT WAS READING APPROXIMATELY 120 SYSTOLIC. THE WAVEFORM WAS GOOD. IT LOOKED LIKE IT WAS NOT CALIBRATED, BUT IT HAD JUST BEEN CALIBRATED. THE PATIENT WAS TREATED WITH ANESTHETIC AND ESMOLOL BASED ON THE HIGH PRESSURE READINGS. THE PROVIDER SET UP ANOTHER ARTERIAL LINE AND PUT IT ON THE PATIENT. THE READINGS ON THE NEW LINE CORRELATED WITH THE BLOOD PRESSURE CUFF. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM WAS REPORTED. THIS IS THE FIRST OF TWO REPORTED EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086122 ↗
• MalfunctionJan 3, 2023High Readings; High Readings

  THE EVENT INVOLVED A TRANSPAC¿ IT MONITORING KIT, 60" PRESSURE TUBING, 3ML FLUSH DEVICE, MACRODRIP. THE DEVICE WAS READING A HIGH PRESSURE ON THE PATIENT THAT DID NOT CORRESPOND TO READINGS ON A BLOOD PRESSURE CUFF. THE REPORTER DID NOT KNOW IF THE PATIENT RECEIVED INCORRECT TREATMENT BASED ON THE INACCURATE READINGS. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM WAS REPORTED. THIS IS THE SECOND OF TWO REPORTED INCIDENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086098 ↗

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