ICU Medical 42598-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709042582), received between Apr 28, 2025 and Jun 26, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Disconnection” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED IN AN UNSPECIFIED DATE IN APRIL 2025 AND INVOLVED A MONITORING KIT W/TP4, 30 ML SQUEEZE FLUSH AND NEEDLELESS VALVE. MEDSUN MEDWATCH MANDATORY AND VOLUNTARY REPORT WITH UF/IMPORTER REPORT # (B)(4) ON 30-MAY-2025, WHICH STATED: FROM STAFF: UMBILICAL ARTERIAL LINE FOUND TO BE LEAKING BLOOD-TINGED FLUID ON BED. BLOOD BACKED UP TO THE TRANSDUCER. BLOOD WAS DRAWN FROM UAC [UMBILICAL ARTERIAL CATHETER] EARLIER IN THE MORNING WITH NO NOTED LEAKING FROM TUBING. THE ORIGINAL INTENDED PROCEDURE WAS CENTRAL LINE CARE FOR PRENATAL MEDICATION. PREEXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT: PREMATURE INFANT. THIS IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED AND REUSED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340813 ↗
• MalfunctionJun 6, 2025Disconnection; Disconnection

  MEDWATCH REPORT (B)(4) RECEIVED STATED THAT "WHILE FLUSHING UAC [UMBILICAL ARTERIAL CATHETER] AFTER OBTAINING LABS PART OF THE TRANSDUCER TUBING DISLODGED FROM CONNECTION SITE AT STOPCOCK (TRANSDUCER SAVED AND GIVEN TO MANAGEMENT). SCRUBBED STOPCOCK X3 WITH CHLORHEXIDINE SWABS AND PLACED A 3ML SYRINGE AT THE END. ORDERED NEW FLUIDS AND CALLED PHARMACY TO HAVE THEM SENT STAT. ENTIRE LINE CHANGED." THIS EVENT OCCURRED ON AN UNSPECIFIED DATE IN FEBRUARY 2025 IN THE CRITICAL CARE AT THE FACILITY. ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER ON 13-MAY-2025: THE FLUID USED TO FLUSH THE TUBING WAS NORMAL SALINE. THE LINE WAS CHANGED AND NEW IV THERAPY HAD TO BE ORDERED AND MADE BY PHARMACY. THERE WAS NO MEDICAL INTERVENTION NEEDED. THERE ARE NO ADDITIONAL CLINICAL COMMENTS OR OBSERVATION REGARDING THESE EVENTS/PRODUCTS. THERE WAS NO HARMED/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158932 ↗
• MalfunctionApr 28, 2025Material Separation; Material Separation

  A COMPLAINT WAS RECEIVED REGARDING A MONITORING KIT W/TP4, 30 ML SQUEEZE FLUSH AND NEEDLELESS VALVE THAT EXPERIENCED SEPARATION DURING USE. THE REPORTER STATED THAT WHILE FLUSHING UAC AFTER OBTAINING LABS PART OF THE TRANSDUCER TUBING DISLODGED FROM CONNECTION SITE AT STOPCOCK. SCRUBBED STOPCOCKX3 WITH CHLORHEXIDINE SWAB AND PLACED A 3ML SYRINGE AT THE END. ORDERED NEW FLUIDS AND CALLED PHARMACY TO HAVE THEM SENT STAT. ENTIRE LINE CHANGED. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT/HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921752 ↗

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-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-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-0542-2017 · Sep 27, 2016 · Terminated
  TP4 Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 46101-53 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravasc
• Z-0466-2017 · Sep 27, 2016 · Terminated
  CATH LAB KIT #3 FOR MARY HITCHCOCK HOSP., Item No. 46063-37 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betw
• 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-0424-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK, Item No. 42582-08 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressur
• Z-0561-2017 · Sep 27, 2016 · Terminated
  Transpac IV Monitoring Kit, 60", 03 ml Squeeze Flush Device, 2 3 Way Stopcocks and Macrodrip, Item No. 46112-10 The Transpac Disposable Straight Pressure Transducer (DSPT) is an ex
• Z-0464-2017 · Sep 27, 2016 · Terminated
  TRANSDUCER KIT W/30ML FLUSH DEVICE FOR CHILDRENS HOSP. OF WISC., Item No. 46063-11 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduc
• Z-0511-2017 · Sep 27, 2016 · Terminated
  TRIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-21 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that
• Z-0565-2017 · Sep 27, 2016 · Terminated
  Transpac IV Trifurcated Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush Device, Needleless Valves, Red, Blue and Yellow Stripe TBG, Item No. 46113-88 The Transpac Disp
• Z-0526-2017 · Sep 27, 2016 · Terminated
  TRIPLE (3) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item No. 46097-65 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascul
• 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-0423-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42582-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfa
• Z-0569-2017 · Sep 27, 2016 · Terminated
  Transpac IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device, PT Tubings, 3-Way Stopcocks and Admin Set, Item No. 46114-80 The Transpac Disposable Straight Pressure Transduce
• Z-0535-2017 · Sep 27, 2016 · Terminated
  DOUBLE LINE KIT W/03ML FLUSH DEVICE & SAFESET, Item No. 46099-18 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces

…and 178 more.