ICU Medical 46115-68Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709087040), received between Sep 3, 2020 and Sep 15, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K052828); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Fluid/Blood Leak

  The event involved a Transpac IV Monitoring Kit 84 inches Disposable Transducer, 3 ml Squeeze Flush Device, Macro drip Un-Bonded reported that the CVP waveform was not displaying appropriately on the monitor. The RN troubleshot the CVP line and identified a crack in the tubing at the connection to the stopcock. Normal saline was noted to be leaking onto the bed for an unknown duration before the issue was recognized. Following identification of the leak, all CVP tubing was replaced. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777260 ↗
• MalfunctionNov 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A TRANSPAC IV MONITORING KIT, 84", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH DEVICE, MACRODRIP UN-BONDED WHERE THE CUSTOMER REPORTED THAT SALINE WAS DRIPPING OUT OF TRANSDUCER PORT NEAR SQUEEZE MECHANISM. ADDITIONALLY, THE CUSTOMER REPORTED, THAT EVERY TIME IT WAS SQUEEZED TO FLUSH, THE FLUID WOULD JUST FLOW OUT OF IT. IT WAS UNKNOWN WHETHER OR NOT THERE WAS PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23577040 ↗
• MalfunctionJun 30, 2025No Flow; No Flow

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TRANSPAC® IV MONITORING KIT, 84", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH DEVICE, MACRODRIP UN-BONDED WHERE IT WAS REPORTED 3 ML FLUSH TRANSDUCER KITS HAVE BEEN HAVING OCCLUSION ISSUES. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22363312 ↗
• MalfunctionSep 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVES A TRANSPAC® IV MONITORING KIT, 84", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH DEVICE, MACRODRIP UN-BONDED THAT THE CUSTOMER REPORTED LEAKING FROM A BONDED SITE BELOW THE TRANSDUCER DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT BUT NO DELAY IN THERAPY, NO ADVERSE EVENT, AND NO HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10488816 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052828. One submission often covers many models, so check the product and lot details in each record.

• Z-1071-2019 · Nov 27, 2018 · Terminated
  ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06