ICU Medical 46116-48Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709089419), received between Sep 7, 2017 and Sep 7, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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.

• MalfunctionSep 7, 2017Leak/Splash; Leak/Splash

  COMPLAINT RECEIVED REGARDING ONE 46116-48, REPORT STATES: TUBING REPORTEDLY PULLED OUT OF MALE DISTAL CONNECTOR AT THE CATHETER SITE. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6848206 ↗

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-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-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-0568-2017 · Sep 27, 2016 · Terminated
  Transpac IV Monitoring Kit w/ Safeset" Reservoir and Blood Sampling Port, 03 ml Squeeze Flush Device, Macrodrip (Patient Mount), Item No. 46114-24 The Transpac Disposable Straight
• 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-0536-2017 · Sep 27, 2016 · Terminated
  Quad Kit W/03ML Flush Device, Mounts, Reservoir & TP4, Item No. 46099-24 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that in
• Z-0468-2017 · Sep 27, 2016 · Terminated
  TRIPLE ANESTHESIA KIT W/03ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46064-54 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transdu
• Z-0432-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV MONITORING KIT, NEONATAL, 24", WITH DISPOSABLE TRANSDUCER, 30 ML INTRAFLO FLUSH (INFUSION PUMP), Item No. 42588-05 The Transpac Disposable Straight Pressure Transducer
• 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-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-0452-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCERS, 2 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42652-05 The Transpac Disposable Straight Pressure T
• 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-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-0472-2017 · Sep 27, 2016 · Terminated
  RIGHT HEART KIT FOR NC BAPTIST HOSPITAL, Item No. 46066-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betwe
• Z-0431-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH, MACRODRIP (POLE MOUNT), Item No. 42587-05 The Transpac Disposable Straight Pressure Transducer (DSPT) i
• Z-0510-2017 · Sep 27, 2016 · Terminated
  BIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-20 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that i

…and 178 more.