ICU Medical 46056-64Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840619068950), received between Nov 9, 2023 and Nov 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

16 other recalls cover devices cleared under the same FDA submission (K932188); 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.

• MalfunctionNov 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE INCIDENT INVOLVED A SAFESET¿ RESERVOIR W/ SS PORT. THE REPORT STATED THAT THE CUSTOMER PRIMED AND ATTACHED AN ICUMEDICAL "SAFESET RESERVOIR W/SS PORT" TO PATIENT'S ARTERIAL LINE, THEN NOTICED SALINE LEAKING FROM THE TUBING AREA AROUND THE SAMPLING PORT. CUSTOMER DISCONNECTED THE SAFESET FROM THE PATIENT AND PRIMED/ATTACHED A NEW ONE. IT APPEARS THERE WAS NO DIRECT PATIENT HARM SINCE THE ERROR WAS CAUGHT. THERE WAS PATIENT INVOLVEMENT, HOWEVER, THERE WAS NO ADVERSE EVENT OR HARM AS AS A RESULT OF THE REPORTED EVENT AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104259 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932188. One submission often covers many models, so check the product and lot details in each record.

• Z-2817-2016 · Aug 10, 2016 · Terminated
  Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduc
• Z-2818-2016 · Aug 10, 2016 · Terminated
  Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that
• Z-2822-2016 · Aug 10, 2016 · Terminated
  5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interface
• Z-2821-2016 · Aug 10, 2016 · Terminated
  Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that i
• Z-2828-2016 · Aug 10, 2016 · Terminated
  Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needleless Valve, Item No. 46112-65 Product Usage: The Transpac Disposable Straight Pressure
• Z-2823-2016 · Aug 10, 2016 · Terminated
  Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46103-22 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular press
• Z-2820-2016 · Aug 10, 2016 · Terminated
  Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduc
• Z-2825-2016 · Aug 10, 2016 · Terminated
  TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set, Item No. 46104-65 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an e
• Z-2807-2016 · Aug 10, 2016 · Terminated
  Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 42500-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT
• Z-2815-2016 · Aug 10, 2016 · Terminated
  Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that
• Z-2813-2016 · Aug 10, 2016 · Terminated
  Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valves, Item No. 42650-66 Product Usage: The Transpac Disposable Straight P
• Z-2811-2016 · Aug 10, 2016 · Terminated
  Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24" Tubing, Disposable Transducer, 03 mL Squeeze Flush, Macrodrip (Patient Mount), Item No. 42648-06 P
• Z-0617-05 · Nov 2, 2004 · Terminated
  Angiographic Syringe, 10 cc Thumb Ring with Rotator Reservoir.
• Z-0618-05 · Nov 2, 2004 · Terminated
  Angiographic Syringe, 12 cc Thumb Ring with Rotator Reservoir.
• Z-0620-05 · Nov 2, 2004 · Terminated
  Angiographic Syringe, 12 cc Palm Pad with Rotator Reservoir.

…and 1 more.