ICU Medical 42585-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840619033804), received between Apr 9, 2020 and Jan 19, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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

• MalfunctionJan 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A TRANSPAC® IV MONITORING KIT, 84", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP. THE REPORTER STATED THAT DRIP CHAMBER WAS LEAKING, WHEN THE DEVICE WAS ACTIVELY BEING USED FOR MONITORING A PATIENT'S CENTRAL VENOUS PRESSURE (CVP) ON A CENTRAL LINE. PATIENT CARE WAS DELAYED WHILE STAFF SWAPPED OUT THE DEVICE. THERE WAS NO REPORT OF ANY HUMAN HARM ASSOCIATED WITH THIS COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21187946 ↗
• MalfunctionApr 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED IN THE OPERATING ROOM AND INVOLVED A TRANSPAC IV MONITORING KIT, 84¿ DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP THAT DURING PRIMING, THE PRESSURE TUBING CONNECTION RIGHT AFTER THE FLUSH DEVICE WAS LEAKING. THE DEVICE WAS REPLACED. THERE WERE NO OBVIOUS DEFECTS NOTED ON THE TUBING AND THERE WAS NO MATING DEVICE ATTACHED ON THE TUBING. THERE WAS NO SERIOUS INJURY, DEATH OR POTENTIAL FOR DEATH OR SERIOUS INJURY, THE PRODUCT WAS NOT USED ON A PATIENT AT THE TIME OF THE INCIDENT AND THERE WAS NO DELAY CRITICAL THERAPY WHEN THE PROBLEM WAS NOTED.

  Patient problems: No Patient Involvement

  MAUDE report 9944395 ↗

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-0512-2017 · Sep 27, 2016 · Terminated
  MONITORING KIT WITH 03ML FLUSH DEVICE FOR NYU MED CTR, Item No. 46094-37 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that in
• Z-0520-2017 · Sep 27, 2016 · Terminated
  CATH LAB KIT w/3 PORT ''ON'' MANIFOLD, WASTE BAG, TP4, SYRINGES & 30 ml BURETTE, Item No. 46096-26 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular p
• Z-0552-2017 · Sep 27, 2016 · Terminated
  Transpac IV Monitoring Kit, 60", Disposable Transducer, 30 ML Intraflo Flush, Pall Air Filter, Macrodrip (Pole Mount), Item No. 46104-63 The Transpac Disposable Straight Pressure T
• 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-0459-2017 · Sep 27, 2016 · Terminated
  MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL, Item No. 46054-42 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer tha
• Z-0508-2017 · Sep 27, 2016 · Terminated
  PEDIATRIC CVL MONITORING KIT W/03ML FLUSH DEVICE FOR YALE NEW HAVEN HOSP., Item No. 46094-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressur
• Z-0563-2017 · Sep 27, 2016 · Terminated
  Transpac IV Disposable Transducer w/Stopcocks w/o Cap and Covers, Item No. 46112-30NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure trans
• Z-0515-2017 · Sep 27, 2016 · Terminated
  Neonate Kit With 30 ml Flush Device For Driscoll Foundation For Children, Item No. 46094-71 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure
• Z-0492-2017 · Sep 27, 2016 · Terminated
  MONITORING KIT WITH 03ML FLUSH DEVICE FOR LEHIGH VALLEY HOSPITAL CENTER, Item No. 46085-47 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure
• Z-0537-2017 · Sep 27, 2016 · Terminated
  CARDIAC KIT WITH 03 ml FLUSH DEVICE, Item No. 46099-57 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a
• Z-0483-2017 · Sep 27, 2016 · Terminated
  TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR ALL CHILDRENS HOSP., Item No. 46076-21 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer
• Z-0566-2017 · Sep 27, 2016 · Terminated
  Transpac IV Trifurcated Monitoring Kit 84" w/03 ml Squeeze Flush Device, Red, Blue and Yellow Stripe Tubing, Item No. 46113-90 The Transpac Disposable Straight Pressure Transducer
• 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-0473-2017 · Sep 27, 2016 · Terminated
  M.K. WITH 03ML FLUSH DEVICE FOR DRISCOLL FOUNDATION CHILDRENS HOSP., Item No. 46068-02 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure tran
• Z-0435-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV TRIFURCATED MONITORING KIT, 84" 3 DISPOSABLE TRANSDUCERS WITH 2 STOPCOCKS 3 3 ML SQUEEZE FLUSHES, MACRODRIP (POLE MOUNT), Item No. 42590-08 The Transpac Disposable Stra

…and 178 more.