ICU Medical 46114-74Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709080171), received between Jul 11, 2025 and Jul 11, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Sensing Problem” (1 report).

193 other recalls cover devices cleared under the same FDA submission (K061573); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2025Device Sensing Problem; Device Sensing Problem

  A COMPLAINT WAS RECEIVED REGARDING A TRANSPAC® IV DISPOSABLE MONITORING KIT W/BONDED STOPCOCK, SELF-RETAINING CAP AND 30 ML SQUEEZE FLUSH DEVICE THAT EXPERIENCED DEVICE INACCURACY. IT WAS STATED THAT THE NICU RN REPORTED THAT TRANSDUCER WILL NOT GIVE A CONSISTENT READING FOR A-LINE BP. THE DEVICE ZEROED MULTIPLE TIMES, THEN CABLE CHANGED OUT, AND MULTIPLE NURSES ATTEMPTED TO TROUBLE SHOOT PROBLEM. THE MONITOR WILL ONLY CONSISTENTLY GIVE NUMBER IN PARATHESIS BUT NOT ACTUAL BP READING. UAC IS NEW THIS AM, PATENT WHEN FLUSHED, AND IT DOES DRAW BACK. THE EVENT DATE OCCURRED 12-JUN-2025 AT 1:58 PM. THE SAMPLE IS AVAILABLE FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM AND UNKNOWN DELAY IN THERAPY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22487789 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061573. One submission often covers many models, so check the product and lot details in each record.

• Z-0419-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42500-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfa
• Z-0504-2017 · Sep 27, 2016 · Terminated
  ARTERIAL PRESSURE KIT W/03ML FLUSH DEVICE FOR LEBONHEUR CHILDRENS HOSP., Item No. 46091-31 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure
• Z-0427-2017 · Sep 27, 2016 · Terminated
  Transpac IV Monitoring Kit, 60", Disposable Transducer, 3 ml Squeeze Flush Device, Macrodrip, Item No. 42584-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an ex
• Z-0500-2017 · Sep 27, 2016 · Terminated
  CATH LAB KIT WITH 03ML FLUSH DEVICE FOR MEMORIAL HEALTHCARE, Item No. 46090-07 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer t
• Z-0495-2017 · Sep 27, 2016 · Terminated
  ADD-ON DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP., Item No. 46086-21 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure tran
• Z-0519-2017 · Sep 27, 2016 · Terminated
  CATH LAB KIT, Item No. 46096-25 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure
• Z-0421-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV BIFURCATED MONITORING KIT, 72" 2 DISPOSABLE TRANSDUCERS, with 2 STOPCOCKS, 2 3 ml SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42500-19 The Transpac Disposable Strai
• Z-0418-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV MONITORING KIT WITH 2 BONDED STOPCOCKS, 72", DISPOSABLE TRANSDUCER WITH 2 BONDED STOPCOCKS, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42500-02 The Transpac D
• Z-0442-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV MONITORING KIT WITH 2 SAFESET" BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42620-08 The Transpac Dispo
• Z-0513-2017 · Sep 27, 2016 · Terminated
  QUAD KIT WITH THREE TRANSPAC AND 03ML FLUSH DEVICES FOR ST. FRANCIS HOSP., Item No. 46094-47 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressur
• Z-0437-2017 · Sep 27, 2016 · Terminated
  Transpac IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24" Arterial Pressure Tubing, Item No. 42594-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an ex
• Z-0494-2017 · Sep 27, 2016 · Terminated
  TRIFURCATED DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP, Item No. 46086-20 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure
• Z-0491-2017 · Sep 27, 2016 · Terminated
  Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifold and Transpac IV Disposable Transducer, Item No. 46083-03 The Transpac Disposable Straigh
• Z-0476-2017 · Sep 27, 2016 · Terminated
  NEONATAL KIT WITH 30ML FLUSH DEVICE FOR YALE-NEW HAVEN HOSP., Item No. 46068-65 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer
• Z-0430-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (INFUSION PUMP), Item No. 42586-05 The Transpac Disposable Straight Pressure Transducer (DSPT)

…and 178 more.