Transpac™ 46115-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00887709082496), received between Feb 22, 2019 and Aug 3, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Fluid/Blood Leak; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50112770 ↗
• MalfunctionApr 30, 2024Break; Material Separation; Break; Material Separation

  THE EVENT INVOLVED A TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, NEEDLELESS VALVE, 10 CC CONTAMINATION SHEATH SYRINGE AND ADMIN SET WHERE IT WAS REPORTED THAT DURING PATIENT USE, THAT THE ARTERIAL LINES BROKE WHILE IN USE. THERE WAS PATIENT INVOLVED AND HARM REPORTED BUT NO ADVERSE EVENT OR DEATH REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED ON THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19218485 ↗
• MalfunctionApr 29, 2024Break; Separation Problem; Break; Separation Problem

  THE EVENT INVOLVED A TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAMPLING PORT, 10 CC CONTAMINATION SHEATH SYRINGE AND ADMIN SET WHERE THE CUSTOMER REPORTED THAT THE ARTERIAL PRESSURE TUBING WAS BREAKING MID LINE WHILE IN USE WITH PATIENT. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENTS OR UNKNOWN HUMAN HARM. THIS IS THE THIRD OF THREE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202052 ↗
• MalfunctionApr 29, 2024Break; Separation Problem; Break; Separation Problem

  THE EVENT INVOLVED A TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAMPLING PORT, 10 CC CONTAMINATION SHEATH SYRINGE AND ADMIN SET WHERE THE CUSTOMER REPORTED THAT THE ARTERIAL PRESSURE TUBING WAS BREAKING MID LINE WHILE IN USE WITH PATIENT. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENTS OR UNKNOWN HUMAN HARM. THIS IS THE SECOND OF THREE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202047 ↗
• MalfunctionApr 29, 2024Break; Separation Problem; Break; Separation Problem

  THE EVENT INVOLVED A TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAMPLING PORT, 10 CC CONTAMINATION SHEATH SYRINGE AND ADMIN SET WHERE THE CUSTOMER REPORTED THAT THE ARTERIAL PRESSURE TUBING WAS BREAKING MID LINE WHILE IN USE WITH PATIENT. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENTS OR UNKNOWN HUMAN HARM. THIS IS THE FIRST OF THREE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202046 ↗
• MalfunctionFeb 2, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAMPLING PORT, 10 CC CONTAMINATION SHEATH SYRINGE AND ADMIN SET. THE CUSTOMER REPORTED THAT THE ARTERIAL PRESSURE TUBING SNAPPED APART IN THE MIDDLE OF THE TUBING (NOT NEAR THE CONNECTION SITES) IMMEDIATELY UPON USE AT THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT OR HUMAN HARM. THIS IS THE FOURTH OF FOUR REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18634013 ↗
• MalfunctionFeb 2, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAMPLING PORT, 10 CC CONTAMINATION SHEATH SYRINGE AND ADMIN SET. THE CUSTOMER REPORTED THAT THE ARTERIAL PRESSURE TUBING SNAPPED APART IN THE MIDDLE OF THE TUBING (NOT NEAR THE CONNECTION SITES) IMMEDIATELY UPON USE AT THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT OR HUMAN HARM. THIS IS THE SECOND OF FOUR REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18633839 ↗
• MalfunctionFeb 2, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAMPLING PORT, 10 CC CONTAMINATION SHEATH SYRINGE AND ADMIN SET. THE CUSTOMER REPORTED THAT THE ARTERIAL PRESSURE TUBING SNAPPED APART IN THE MIDDLE OF THE TUBING (NOT NEAR THE CONNECTION SITES) IMMEDIATELY UPON USE AT THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT OR HUMAN HARM. THIS IS THE THIRD OF FOUR REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18633790 ↗
• MalfunctionFeb 2, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAMPLING PORT, 10 CC CONTAMINATION SHEATH SYRINGE AND ADMIN SET. THE CUSTOMER REPORTED THAT THE ARTERIAL PRESSURE TUBING SNAPPED APART IN THE MIDDLE OF THE TUBING (NOT NEAR THE CONNECTION SITES) IMMEDIATELY UPON USE AT THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT OR HUMAN HARM. THIS IS THE FIRST OF FOUR REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18633445 ↗
• MalfunctionFeb 22, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE EVENT BECAME DISCONNECTED AT A SITE BELOW THE STOPCOCK DURING USE ON A PATIENT. THE REPORTER STATED, THE PATIENT LOSS AN UNSPECIFIED AMOUNT OF BLOOD DUE TO THE DISCONNECTION. THERE WAS REPORTED TO BE A DELAY IN CRITICAL THERAPY BUT NO OTHER HARM TO THE PATIENT IS KNOWN AT THIS TIME.

  Patient problems: Blood Loss

  MAUDE report 8363280 ↗

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