ICU Medical 852-011-46104-58Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840619097424), received between Jun 24, 2020 and Jul 23, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Disconnection” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE CUSTOMER REPORTED AN ISSUE WITH A TRANSPAC IV MONITORING KIT, STATING THAT THE TUBING AND CAP WERE DISLODGED BEFORE PRIMING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM. TESTING WAS PERFORMED ON THE RETURNED DEVICE THE REPORTED PROBLEM WAS CONFIRMED. AN IMAGE WAS PROVIDED BY THE CUSTOMER SHOWING THE AREA OF THE DEFECT. HOWEVER, THE RETURNED SAMPLE DOES NOT MATCH WITH THE IMAGE PROVIDED. DURING VISUAL INSPECTION, THE 12.5" PRESSURE TUBING WAS FOUND SEPARATED FROM THE MALE LUER. THE PRESSURE TUBING WAS FOUND TACKY AT THE BOND SITE. THE PROBABLE CAUSE OF THE PRESSURE TUBING BEING TACKY HAD OCCURRED DUE TO THE SOLVENT ON THE TUBING NOT BEING FULLY CURED DURING ASSEMBLY PROCESS. A LOT REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12217091 ↗
• MalfunctionJun 24, 2020Disconnection; Disconnection

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TRANSPAC IV MONITORING KIT THAT DISCONNECTED BETWEEN THE TUBING AND THE 3-WAY CONNECTOR. THERE WAS NO PATIENT INVOLVED AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10189221 ↗

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-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
• Z-0542-2017 · Sep 27, 2016 · Terminated
  TP4 Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 46101-53 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravasc
• Z-0507-2017 · Sep 27, 2016 · Terminated
  CATH LAB KIT FOR SALINA REGIONAL, Item No. 46092-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a ca
• Z-0460-2017 · Sep 27, 2016 · Terminated
  CATH LAB KIT #2 FOR MARY HITCHCOCK MEM. HOSP., Item No. 46057-18 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces
• Z-0457-2017 · Sep 27, 2016 · Terminated
  CATH LAB KIT FOR ALBERT EINSTEIN M.C., Item No. 46047-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between
• Z-0525-2017 · Sep 27, 2016 · Terminated
  TRANSDUCER KIT FOR MEDICAL CTR. AT BOWLING GREEN, Item No. 46097-64 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfa
• Z-0453-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK WITHOUT COVERS, Item No. 42663-01NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extr
• Z-0508-2017 · Sep 27, 2016 · Terminated
  PEDIATRIC CVL MONITORING KIT W/03ML FLUSH DEVICE FOR YALE NEW HAVEN HOSP., Item No. 46094-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressur
• 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
• Z-0459-2017 · Sep 27, 2016 · Terminated
  MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL, Item No. 46054-42 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer tha
• Z-0570-2017 · Sep 27, 2016 · Terminated
  Cath Lab Kit w/3 Port "ON" Manifold (600 psi), Transpac IV, 2 Admin Sets and 8 cc Control Syringe, Item No. 46300-01 The Transpac Disposable Straight Pressure Transducer (DSPT) is
• 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-0489-2017 · Sep 27, 2016 · Terminated
  TRIPLE KIT W/SAFESET" AND 03ML FLUSH DEVICE FOR O.H.S.U., Item No. 46080-38 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that
• Z-0452-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCERS, 2 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42652-05 The Transpac Disposable Straight Pressure T
• Z-0466-2017 · Sep 27, 2016 · Terminated
  CATH LAB KIT #3 FOR MARY HITCHCOCK HOSP., Item No. 46063-37 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betw

…and 178 more.