ICU Medical 42646-66Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709042605), received between Nov 21, 2023 and Nov 21, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionNov 21, 2023Material Separation; Material Separation

  THE MANUFACTURER RECEIVED A MEDSUN MANDATORY MEDWATCH REPORT (UF/IMPORTER REPORT# (B)(4)). THE INCIDENT INVOLVED A TRANSPAC® IV MONITORING KIT W/SAFESET 84" ARTERIAL PRESSURE TUBING, RESERVOIR,03 ML SQUEEZE FLUSH AND 2 NEEDLELESS VALVES. THE REPORT STATED THAT THE STATLOCK TUBING FROM THE ARTERIAL LINE SEVERED DURING ATTACHMENT TO A BRAND NEW TRANSDUCER SET-UP. IT SEEMS IT WAS THE STATLOCK TUBING THAT SEVERED (NOT THE TRANSDUCER TUBING). MEANING THE TRANSDUCER IS INTACT BUT THE END OF THE TRANSDUCER THAT IS AFFIXED TO THE STATLOCK TUBING SEVERED. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18183494 ↗

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-0429-2017 · Sep 27, 2016 · Terminated
  Transpac IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip, Item No. 42585-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravasc
• 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-0450-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCER, 2 3 ML INTRAFLO FLUSHES, MACRODRIP (POLE MOUNT), Item No. 42651-05 The Transpac Disposable Straight Pressure
• Z-0477-2017 · Sep 27, 2016 · Terminated
  KIT W/30ML FLUSH DEVICE FOR ALL CHILDRENS Hospital, Item No. 46070-30 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that inter
• Z-0564-2017 · Sep 27, 2016 · Terminated
  Transpac IV Kit w/2 3-Way Stopcocks and 48" Pressure TBG, Item No. 46112-77 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that
• Z-0560-2017 · Sep 27, 2016 · Terminated
  Transpac IV Trifurcated Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset" Reservoir and Needleless Valves, Item No. 46112-05 The Transpac Disposable Straight Pressure
• Z-0545-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV TRIFURCATED MONITORING KIT 72", 3 DISPOSABLE TRANSDUCERS, 3 3 ML INTRAFLO FLUSHES, MACRODRIP (POLE MOUNT), Item No. 46101-39 The Transpac Disposable Straight Pressure T
• Z-0436-2017 · 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-0518-2017 · Sep 27, 2016 · Terminated
  CARDIAC CATH LAB KIT FOR PRESBYTERIAN INTERCOMMUNITY HOSP., Item No. 46095-33 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer th
• Z-0420-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV BIFURCATED KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORTS, 84" TUBING, 2 SQUEEZE FLUSHES, 2 DISPOSABLE TRANSDUCER, MACRODRIP (POLE MOUNT), Item No. 42500-06 The T
• Z-0562-2017 · Sep 27, 2016 · Terminated
  Transpac IV Monitoring Kit w/Arterial 84" Safeset" Reservoir, 03 ml Squeeze Flush Device and Needleless Valves, Item No. 46112-13 The Transpac Disposable Straight Pressure Transduc
• Z-0441-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV MONITORING KIT , 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH, MICRODRIP (POLE MOUNT), Item No. 42608-05 The Transpac Disposable Straight Pressure Transducer (DSPT)
• Z-0438-2017 · Sep 27, 2016 · Terminated
  Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 42598-01 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduce
• Z-0488-2017 · Sep 27, 2016 · Terminated
  CATH LAB KIT FOR BAPTIST M. C., Item No. 46078-52 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a cath
• 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.