ICU Medical 42632-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840619033811), received between Jan 3, 2018 and Apr 20, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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.

• MalfunctionApr 20, 2021Material Separation; Material Separation

  THE EVENT OCCURRED AT 9:00 AM AND INVOLVED A TRANSPAC® IV MONITORING KIT, 72" (183 CM), DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH DEVICE, MACRODRIP (POLE MOUNT) THAT THE CUSTOMER REPORTED BLOOD BACKING UP INTO THE TRANSDUCER TUBING. THE LINE WAS TRACED BACK AND IT WAS NOTED TO HAVE DISCONNECTED ABOVE ONE OF THE LUER LOCK CONNECTORS OF THE TRANSDUCER LINE. ADDITIONALLY, IT WAS MENTIONED THE TUBING CAME DISCONNECTED FROM THE LUER PLASTIC. THE DEVICE WAS CLAMPED TO CONTROL THE BLOOD FLOW AND THE TRANSDUCER WAS REPLACED. THERE WAS NO PATIENT HARM AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697907 ↗
• MalfunctionJan 3, 2018Detachment Of Device Component; Detachment Of Device Component

  THE EVENT INVOLVED A CUSTOMER REPORT OF A TRANSPAC IV MONITORING KIT THAT DISCONNECTED AT THE CONNECTION OF THE DEVICE. IT WAS REPORTED THAT THERE WAS SUSPICION OF MISSING SOLVENT TO GLUE IT PROPERLY. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7161807 ↗

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-0467-2017 · Sep 27, 2016 · Terminated
  OPEN HEART KIT WITH 03ML FLUSH DEVICE FOR FLETCHER ALLEN HEALTH CARE, Item No. 46063-77 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure tra
• Z-0447-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42642-06 The Tra
• Z-0434-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV TRIFURCATED MONITORING KIT 60 INCH, 3 DISPOSABLE TRANSDUCERS, 3 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42590-05 The Transpac Disposable Straight Pressure
• Z-0482-2017 · Sep 27, 2016 · Terminated
  MONITORING KIT W/03ML FLUSH DEVICE FOR PITT CO. MEM. HOSP., Item No. 46076-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer th
• Z-0472-2017 · Sep 27, 2016 · Terminated
  RIGHT HEART KIT FOR NC BAPTIST HOSPITAL, Item No. 46066-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betwe
• Z-0483-2017 · Sep 27, 2016 · Terminated
  TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR ALL CHILDRENS HOSP., Item No. 46076-21 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer
• Z-0513-2017 · Sep 27, 2016 · Terminated
  QUAD KIT WITH THREE TRANSPAC AND 03ML FLUSH DEVICES FOR ST. FRANCIS HOSP., Item No. 46094-47 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressur
• Z-0535-2017 · Sep 27, 2016 · Terminated
  DOUBLE LINE KIT W/03ML FLUSH DEVICE & SAFESET, Item No. 46099-18 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces
• Z-0575-2017 · Sep 27, 2016 · Terminated
  LEFT HEART KIT, Item No. AG8052-NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressu
• Z-0537-2017 · Sep 27, 2016 · Terminated
  CARDIAC KIT WITH 03 ml FLUSH DEVICE, Item No. 46099-57 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a
• Z-0528-2017 · Sep 27, 2016 · Terminated
  Cath Lab Kit w/Waste Bag, dyePod, Sosa Spike & Syringe, Item No. 46098-11 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that i
• Z-0526-2017 · Sep 27, 2016 · Terminated
  TRIPLE (3) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item No. 46097-65 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascul
• Z-0567-2017 · Sep 27, 2016 · Terminated
  Transpac IV Monitoring Kit w/84" Red Stripe TBG and 03 ml Squeeze Flush Device, Item No. 46113-91 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pr
• Z-0439-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV MONITORING KIT WITH DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH AND MACRODRIP (POLE MOUNT), Item No. 42606-05 The Transpac Disposable Straight Pressure Transducer (DSPT)

…and 178 more.