ICU Medical 42648-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840619045012), received between Mar 1, 2018 and Jan 29, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 reports).

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

• MalfunctionJan 29, 2019Material Separation; Material Separation

  THE EVENT INVOLVED A TRANSPAC WHERE UPON SET UP THE CONNECTION FELL APART AT THE BLOOD SAMPLING PORT. THERE WAS NO REPORT OF HUMAN HARM, NOR ADVERSE EVENT, NOR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8286763 ↗
• MalfunctionJan 25, 2019Material Separation; Material Separation

  USER FACILITY MEDWATCH RECEIVED WITH ADDITIONAL INFORMATION STATING THAT THE ORIGINAL INTENDED PROCEDURE WAS ARTERIAL LINE MONITORING AND THE PATIENT WAS IN THE PEDIATRIC INTENSIVE CARE UNIT (PICU).

  Patient problems: No Patient Involvement

  MAUDE report 8278279 ↗
• MalfunctionDec 6, 2018Material Separation; Material Separation

  THE EVENT INVOLVED A TRANSPAC IV MONITORING KIT W/SAFESET RESERVOIR AND BLOOD SAMPLING PORT WHERE THE TUBING ADJACENT TO THE BLOOD SAMPLING PORT PULLED LOOSE. THE PRODUCT WAS REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED AND IS AVAILABLE FOR INVESTIGATION. THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARMED OR ADVERSE EVENT AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8139112 ↗
• MalfunctionMar 1, 2018Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THE ARTERIAL LINE BECAME DISCONNECTED AT A JUNCTION POINT DURING PATIENT USE. IT WAS REPORTED THAT THE MONITOR WAS ABLE TO SENSE AN ARTERIAL LINE DISCONNECTION. THERE WAS A SMALL AMOUNT OF BLOOD LOSS REPORTED BUT NO REPORT OF ADVERSE EVENT OR DELAY IN CRITICAL THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7307640 ↗

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-0552-2017 · Sep 27, 2016 · Terminated
  Transpac IV Monitoring Kit, 60", Disposable Transducer, 30 ML Intraflo Flush, Pall Air Filter, Macrodrip (Pole Mount), Item No. 46104-63 The Transpac Disposable Straight Pressure T
• Z-0494-2017 · Sep 27, 2016 · Terminated
  TRIFURCATED DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP, Item No. 46086-20 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure
• Z-0491-2017 · Sep 27, 2016 · Terminated
  Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifold and Transpac IV Disposable Transducer, Item No. 46083-03 The Transpac Disposable Straigh
• Z-0436-2017 · Sep 27, 2016 · Terminated
  Transpac IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24" Arterial Pressure Tubing, Item No. 42594-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an ex
• 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
• 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-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-0550-2017 · Sep 27, 2016 · Terminated
  Transpac IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip, Red Stripe Pressure Tubing and Color Plug, Item No. 46104-31 The Transpac Disposable Straight
• Z-0566-2017 · Sep 27, 2016 · Terminated
  Transpac IV Trifurcated Monitoring Kit 84" w/03 ml Squeeze Flush Device, Red, Blue and Yellow Stripe Tubing, Item No. 46113-90 The Transpac Disposable Straight Pressure Transducer
• 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-0555-2017 · Sep 27, 2016 · Terminated
  Transpac IV Monitoring Kit w/03 ml Squeeze Flush and Macrodrip, Item No. 46106-91 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduce
• Z-0556-2017 · Sep 27, 2016 · Terminated
  Bifurcated Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, Red and Blue Stripe PT Tubing, Item No. 46107-68 The Transpac Disposable Straight Pressure Transducer (DSPT) is
• Z-0503-2017 · Sep 27, 2016 · Terminated
  MONITORING KIT WITH 03ML FLUSH DEVICE FOR CONCORD HOSP., Item No. 46091-13 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that
• 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-0422-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV DISPOSABLE TRANSDUCER, Item No. 42582-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a c

…and 178 more.