ICU Medical 42650-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840619045029), received between Dec 17, 2018 and Oct 2, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2024Leak/Splash; Material Separation; Leak/Splash; Material Separation

  THE EVENT INVOLVED A TRANSPAC¿ TRIFURCATED MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING PORTS, 84", 3 3 ML SQUEEZE FLUSHES, 3 DISPOSABLE TRANSDUCERS, MACRODRIP (POLE MOUNT) WHERE THE CUSTOMER REPORTED THAT THE TUBING SNAPPED WHILE TAKING A PATIENT TO CT. THE CUSTOMER SAID THIS SEEMED TO BE HAPPENING MORE OFTEN. THE CUSTOMER STATED THAT THERE WAS A SMALL AMOUNT OF BLOOD LOSS AND THEN A LARGE CLOT WAS FOUND IN THE TUBING; THE NURSE CHECKED LINE/PULLED BACK PRIOR TO FLUSHING AND WAS ABLE TO WITHDRAW THE CLOT. THERE WAS ABOUT A 20 MINUTE DELAY IN THERAPY DUE TO NOT OBTAINING/ABLE TO READ CONTINUOUS BLOOD PRESSURE THROUGHOUT SCAN; THE NURSE USED CUFF PRESSURES INSTEAD. THERE WAS PATIENT INVOLVEMENT; BUT NO ADVERSE OUTCOME OCCURRED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20351429 ↗
• MalfunctionSep 25, 2024Disconnection; Disconnection

  THE EVENT INVOLVED A TRANSPAC¿ TRIFURCATED MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING PORTS, 84", 3 3 ML SQUEEZE FLUSHES, 3 DISPOSABLE TRANSDUCERS, MACRODRIP (POLE MOUNT) WHERE IT WAS REPORTED THAT THE TUBE DISCONNECTED ON A PATIENT. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302486 ↗
• MalfunctionJul 1, 2024Material Separation; Material Separation

  THE EVENT INVOLVED A TRANSPAC¿ TRIFURCATED MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING PORTS, 84", 3 3 ML SQUEEZE FLUSHES, 3 DISPOSABLE TRANSDUCERS, MACRODRIP (POLE MOUNT) AND OCCURED ON AN UNSPECIFIED DATE. IT WAS REPORTED THAT THE DEVICE HAD A "BROKEN ART LINE KIT". THERE WAS PATIENT INVOLVEMENT AND HARM/ADVERSE EVENT REPORT . THE PATIENT WAS FOUND BLEEDING PROFUSELY FROM HIS ARM.NO ADDITIONAL INFORMATION WAS PROVIDED ON THIS CASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19652576 ↗
• MalfunctionApr 4, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 19-TRANSPAC¿ TRIFURCATED MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING PORTS, 84", 3 3 ML SQUEEZE FLUSHES, 3 DISPOSABLE TRANSDUCERS, MACRODRIP (POLE MOUNT) WHERE IT WAS REPORTED THAT THE GREEN STOP IS CUTTING THE TUBING. IT WAS FURTHER STATED THAT IT HAPPENED WITH THE TRIPLE AND SINGLE SAFE SETS ON THE ARTERIAL LINES SNAPPING IN HALF. THERE IS UNKNOWN PATIENT INVOLVEMENT, THERE WAS UNKNOWN PATIENT HARM, AND UNKNOWN DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19043488 ↗
• MalfunctionDec 17, 2018Material Separation; Material Separation

  USER FACILITY MEDWATCH WAS RECEIVED THAT STATED THE FOLLOWING: ¿UPON PULLING A BLOOD SAMPLE FROM THE INTEGRATED SYRINGE PLUNGER, A SPECIMEN WAS UNABLE TO BE PULLED AND BLOOD LEAKED OUT BEHIND THE SYRINGE PLUNGER AND OUT THE PLUNGER HOLE ONTO THE USER¿S HANDS. THE BLACK RUBBER PIECE WAS ABLE TO BE ATTACHED BACK TO THE PLUNGER." THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN HUMAN HARM OR ADVERSE EVENT, AND UNKNOWN DELAY IN CRITICAL THERAPY. NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8170916 ↗

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-0447-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42642-06 The Tra
• 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-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-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-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)
• Z-0529-2017 · Sep 27, 2016 · Terminated
  Cath Lab Kit w/03 ml Intraflo, 2 Port Manifold Right OFF Rotator and TP4, Item No. 46098-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressur
• Z-0523-2017 · Sep 27, 2016 · Terminated
  QUAD TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUBBOCK HEART HOSP., Item No. 46097-36 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure trans
• Z-0455-2017 · Sep 27, 2016 · Terminated
  Monitoring Kit #3 w/03 ml Flush Device for Childrens Hosp, Item No. 46010-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer tha
• Z-0548-2017 · Sep 27, 2016 · Terminated
  Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46104-07 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduce
• Z-0485-2017 · Sep 27, 2016 · Terminated
  Double LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-26 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduce
• Z-0499-2017 · Sep 27, 2016 · Terminated
  CATH LAB KIT FOR GENESIS HEALTH CARE, Item No. 46089-74 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between
• Z-0426-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV MONITORING KIT DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (INTENDED FOR PATIENT MOUNT), Item No. 42583-05 The Transpac Disposable Straight Pressure Transducer
• 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-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-0502-2017 · Sep 27, 2016 · Terminated
  CVP ARTERIAL LINE KIT WITH 03ML FLUSH DEVICE FOR KANSAS HEART HOSP, Item No. 46091-04 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure trans

…and 178 more.