ICU Medical 42801-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709120679), received between May 14, 2025 and Aug 4, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2025Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  THE COMPLAINT INVOLVED A TRANSPAC¿ IT MONITORING KIT, 84" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MACRODRIP DEVICE. UPON DISCONNECTING AND RECONNECTING THE PATIENT'S ARTERIAL LINE/SETUP TO AN EXISTING ARTERIAL LINE TUBING FOR LINE CHANGE, THE LINE WAS REPORTEDLY LEAKING BLOOD FROM THE EXISTING TUBING CONNECTED TO PATIENT ARTERIAL LINE CATHETER. ALSO, WHEN ATTEMPTING TO ASPIRATE BLOOD, THE DEVICE ALSO PULLED AIR INTO THE SETUP. THERE WERE NO OTHER DEVICES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE PATIENT INVOLVED WAS A 24.3 YEARS OLD, MALE AND WITH UNSPECIFIED PATIENT HARM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 22700420 ↗
• MalfunctionMay 14, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE COMPLAINT/EVENT INVOLVED A TRANSPAC¿ IT MONITORING KIT, 84" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MACRODRIP THAT REPORTEDLY GENERATED AN ARTERIAL LINE DAMPENED WAVEFORM DURING INFUSION. THERE WAS NO HUMAN HARM ASSOCIATED WITH THIS REPORTED COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022761 ↗

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