ICU Medical 46115-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709087019), received between Aug 29, 2019 and Sep 13, 2019 — classified as 3 malfunctions.

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

• MalfunctionSep 13, 2019Break; Break

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, THE DEVICE HAD A BROKEN CENTRAL VENOUS PRESSURE (CVP) TUBING. THERE WAS UNKNOWN PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9028064 ↗
• MalfunctionSep 9, 2019Break; Break

  THE EVENT INVOLVED A TRANSPAC® IV TRIFURCATED MONITORING KIT 60", 3 DISPOSABLE TRANSDUCERS, 3 03 ML SQUEEZE FLUSH DEVICES, MACRODRIP (POLEMOUNT) UNBONDED THAT THE CUSTOMER REPORTED THE STOPCOCK BROKE OFF, NOT DISCONNECTED, FROM THE CENTRAL VENOUS PRESSURE (CVP) LINE. THE EVENT OCCURRED IN THE HEART AND VASCULAR INTENSIVE CARE UNIT (HVICU). THE PATIENT HAD BLOOD DOWN HER SIDE AND BACK WHICH WAS TRACED BACK TO THE CVP LINE. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO HARM, NO ADVERSE EVENT, AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 8977260 ↗
• MalfunctionAug 29, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED A TRANSPAC® IV TRIFURCATED MONITORING KIT 60", 3 DISPOSABLE TRANSDUCERS, 3 03 ML SQUEEZE FLUSH DEVICES HAD A BROKEN CENTRAL VENOUS PRESSURE TUBING. THE PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8947118 ↗

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-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-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-0538-2017 · Sep 27, 2016 · Terminated
  Transpac 4 kit w/72" Macrodrip Admin Set, Item No. 46099-77 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betw
• 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-0489-2017 · Sep 27, 2016 · Terminated
  TRIPLE KIT W/SAFESET" AND 03ML FLUSH DEVICE FOR O.H.S.U., Item No. 46080-38 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that
• Z-0575-2017 · Sep 27, 2016 · Terminated
  LEFT HEART KIT, Item No. AG8052-NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressu
• Z-0417-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. 011-46106-45 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascu
• Z-0481-2017 · Sep 27, 2016 · Terminated
  CARDIAC CATHETERIZATION WASTE MANAGEMENT SYSTEM LEFT HEART KIT, Item No. 46073-14 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduce
• 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-0528-2017 · Sep 27, 2016 · Terminated
  Cath Lab Kit w/Waste Bag, dyePod, Sosa Spike & Syringe, Item No. 46098-11 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that i
• Z-0543-2017 · Sep 27, 2016 · Terminated
  Trifurcated Monitoring Kit w/84" Safeset" Reservoir, TP4, 03 ml Squeeze Flush and Needleless Valve, Item No. 46101-55 The Transpac Disposable Straight Pressure Transducer (DSPT) is
• 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-0527-2017 · Sep 27, 2016 · Terminated
  SINGLE (1) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item No. 46097-66 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascul
• Z-0501-2017 · Sep 27, 2016 · Terminated
  Cath Lab Kit W/30ML Flush Device for Monongalia General Hosp, Item No. 46090-62 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer
• 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

…and 178 more.