ICU Medical 42800-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709097964), received between Nov 14, 2024 and Nov 21, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2024Deformation Due to Compressive Stress; Inaccurate Information; Deformation Due to Compressive Stress; Inaccurate Information

  THE EVENT INVOLVED A TRANSPAC¿ IT MONITORING KIT NEONATAL, 12", 3 STOPCOCKS, 30ML FLUSH (FOR USE WITH INFUSION PUMP). THE REPORTER STATED THAT THE PRODUCT WAS INVOLVED IN A PATIENT SAFETY REPORT IN THE FACILITY. THE ISSUE WAS THAT THE IV TUBING WAS BENT CAUSING AN ALARM FOR HIGH PRESSURE. THE WAVEFORM WAS DAMPENED OR WOULD READ AS DISCONNECTED AND WOULD CAUSE ALARMS TO GO OFF. THERE WAS PATIENT INVOLVEMENT AND THERE WAS DELAY IN THERAPY; HOWEVER, THERE WAS NO HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20752410 ↗
• MalfunctionNov 14, 2024Deformation Due to Compressive Stress; Inaccurate Information; Deformation Due to Compressive Stress; Inaccurate Information

  THE EVENT INVOLVED A TRANSPAC¿ IT MONITORING KIT NEONATAL, 12", 3 STOPCOCKS, 30ML FLUSH (FOR USE WITH INFUSION PUMP) WHERE THE REPORTER STATED THAT THE IV TUBING IS BENT CAUSING AN ALARM FOR HIGH PRESSURE. IT WAS STATED THAT WHEN THEY TRIED TO ZERO THE LINE, THE WAVEFORM WAS DAMPENED OR WOULD READ AS DISCONNECTED. IT WOULD CAUSE ALARMS TO GO OFF. AFTER TROUBLESHOOTING WITH A FLEX NURSE, THEY NOTICED THAT THE LINE ENTERING THE TRANSDUCER WAS COMPRESSED DOWN. THEY STRAIGHTENED THE IV TUBING CONNECTING TO THE TRANSDUCER AND GOT AN ACCURATE READING, HOWEVER AS SOON AS RELEASED THE TUBING AGAIN WAS FACED WITH THE SAME ALARMS AND DAMPENED WAVE FORM. THERE WAS PATIENT INVOLVEMENT, AND NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684408 ↗

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