ICU Medical 46116-86Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709091696), received between May 5, 2025 and May 5, 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.

• MalfunctionMay 5, 2025No Flow; No Flow

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TRANSPAC® IV KIT W/35" PT, 6" PT AND 3 NEEDLELESS VALVES WHERE THE CUSTOMER REPORTS THAT THE DEVICE COULD NOT BE FLUSHED THROUGH. THE LINE WAS ASSESSED AT THE PATIENT BEDSIDE AND FOUND TO BE WORKING PROPERLY, BUT THE TRANSDUCER COULD NOT BE FLUSHED THROUGH. THERE WAS PATIENT INVOLVEMENT BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21964252 ↗

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-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-0496-2017 · Sep 27, 2016 · Terminated
  CATH LAB KIT WITH 03ML FLUSH DEVICE FOR CARLE CLINIC, Item No. 46087-37 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-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-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-0504-2017 · Sep 27, 2016 · Terminated
  ARTERIAL PRESSURE KIT W/03ML FLUSH DEVICE FOR LEBONHEUR CHILDRENS HOSP., Item No. 46091-31 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure
• Z-0540-2017 · Sep 27, 2016 · Terminated
  Cath Lab Kit w/Waste Bag System, 3 Port "OFF" Manifold (600 psi), Transpac IV, 72" Spike Sets and 48" HP Tubing, Item No. 46100-83 The Transpac Disposable Straight Pressure Transdu
• Z-0429-2017 · Sep 27, 2016 · Terminated
  Transpac IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip, Item No. 42585-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravasc
• 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-0547-2017 · Sep 27, 2016 · Terminated
  Transpac IV Monitoring Kit w/Safeset 72" Pressure Tubing, Reservoir, 03 ml Squeeze Flush and 2 Needleless Valves, Item No. 46103-77 The Transpac Disposable Straight Pressure Transd
• 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-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-0454-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS AND WITHOUT COVERS, Item No. 42664-01NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure tr
• 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-0509-2017 · Sep 27, 2016 · Terminated
  OPEN HEART KIT W/03ML FLUSH DEVICE FOR CUMBERLAND COUNTY HOSP., Item No. 46094-08 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduce

…and 178 more.