ICU Medical 46101-56Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709050617), received between Nov 25, 2025 and Nov 25, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “No Flow” (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.

• MalfunctionNov 25, 2025No Flow; No Flow

  EVENT OCCURRED REGARDING A SINGLE LINE ARTERIAL KIT W/03 ML PTSF AND TP4 WHERE IT WAS REPORTED THAT THE NURSE WAS DRAWING LABS FROM THE ARTERIAL CATHETER, THE NURSE TURNED THE ARTERIAL LINE OFF TO THE FLUSH BAG AND ATTACHED SYRINGE WITH BLUNT TIP TO THE UPPER SAMPLING PORT. THE NURSE BEGAN TO ASPIRATE THE WASTE AND NOTICED THE SAMPLE APPEARED FOAMY. AS THE NURSE WITHDREW THE SYRINGE FROM THE SAMPLING PORT, BLOOD WAS VISIBLE ON THE PORT. THE NURSE PROCEEDED TO OBTAIN THE SPECIMEN BY ATTACHING A 10 ML SYRINGE WITH BLUNT TIP TO THE LOWER SAMPLING PORT. AS THE NURSE ASPIRATED, THE SAMPLE WAS FOAMY AND MIXTURE OF BLOOD AND AIR. WHEN THE SYRINGE WAS WITHDRAWN, BLOOD LEAKED FROM THE PORT. THE NURSE CONFIRMED THERE WAS NO AIR VISIBLE IN THE HIGH-PRESSURE TUBING, THE HIGH-PRESSURE BAG WAS INFLATED TO 300 MM HG MILLIMETERS OF MERCURY, ALL ACCESS PORTS HAD SOLID CAPS, AND CONNECTIONS ALL TIGHTENED. THE COMMON DEVICE NAME IS TRANSDUCER, BLOOD PRESSURE, EXTRAVASCULAR. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646226 ↗

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-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-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-0470-2017 · Sep 27, 2016 · Terminated
  PEDIATRIC ARTERIAL KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 46065-65 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure tran
• 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-0521-2017 · Sep 27, 2016 · Terminated
  SAFESET" KIT W/03ML FLUSH DEVICE FOR HOLMES REG. M.C., Item No. 46097-30 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that in
• 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-0555-2017 · Sep 27, 2016 · Terminated
  Transpac IV Monitoring Kit w/03 ml Squeeze Flush and Macrodrip, Item No. 46106-91 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduce
• 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-0414-2017 · Sep 27, 2016 · Terminated
  4 Port "ON" Manifold (600 psi) w/4 ft. Transpac IV, Item No. 46300-14NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that int
• Z-0524-2017 · Sep 27, 2016 · Terminated
  TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV. HEALTH SYSTEM, Item No. 46097-62 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer th
• Z-0574-2017 · Sep 27, 2016 · Terminated
  CATH LAB KIT W/3 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE & TP4, Item No. AG7891-NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduce
• 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-0433-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV MONITORING KIT, 9", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH, MACRODRIP (PATIENT MOUNT), Item No. 42589-05 The Transpac Disposable Straight Pressure Transducer (DSPT)
• Z-0545-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV TRIFURCATED MONITORING KIT 72", 3 DISPOSABLE TRANSDUCERS, 3 3 ML INTRAFLO FLUSHES, MACRODRIP (POLE MOUNT), Item No. 46101-39 The Transpac Disposable Straight Pressure T
• Z-0443-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV MONITORING KIT, 72", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42632-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is

…and 178 more.