ICU Medical 852-011-42584-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840619097288), received between Sep 8, 2024 and Sep 8, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3ML SQUEEZE FLUSH DEVICE, MACRODRIP. THE DEVICE REPORTEDLY LEAKED AN UNSPECIFIED NON-CHEMOTHERAPEUTIC DRUG AT THE CONNECTOR. THERE WAS NO PHYSICAL DAMAGE OBSERVED ON THE DEVICE. ALTHOUGH THERE WAS A PATIENT INVOLVED IN THE EVENT/COMPLAINT, THERE WAS NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20165828 ↗

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-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
• Z-0490-2017 · Sep 27, 2016 · Terminated
  MONITORING KIT W/03ML FLUSH DEVICE FOR MEDICAL COLLEGE OF GA, Item No. 46080-51 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer
• 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-0511-2017 · Sep 27, 2016 · Terminated
  TRIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-21 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that
• Z-0424-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK, Item No. 42582-08 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressur
• 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-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-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-0498-2017 · Sep 27, 2016 · Terminated
  TRIFURCATED DISPOSABLE TRANSDUCER KIT W/03ML FLUSH DEVICE FOR JOHNS HOPKINS/BAYVIEW, Item No. 46088-74 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascul
• 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-0497-2017 · Sep 27, 2016 · Terminated
  TRIPLE MK W/03ML FLUSH DEVICE FOR UNIV OF PENN. HEALTH SYSTEMS, Item No. 46088-08 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduce
• Z-0418-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV MONITORING KIT WITH 2 BONDED STOPCOCKS, 72", DISPOSABLE TRANSDUCER WITH 2 BONDED STOPCOCKS, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42500-02 The Transpac D
• Z-0416-2017 · Sep 27, 2016 · Terminated
  Transpac IV Bifurcated Monitoring Kit 48", 2 Disposable Transducers, 2 03 ml Intraflo Flush Devices, Macrodrip (Pole Mount), Item No. 011-42592-05 The Transpac Disposable Straight
• Z-0501-2017 · Sep 27, 2016 · Terminated
  Cath Lab Kit W/30ML Flush Device for Monongalia General Hosp, Item No. 46090-62 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer
• Z-0449-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV MONITORING KIT SAFESET" RESERVOIR AND 2 BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42644-06 The Tran

…and 178 more.