ICU Medical 42303-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840619044169), received between Feb 27, 2026 and Feb 27, 2026 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 27, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A SAFESET SHIELDED BLUNT CANNULA, AND IT WAS REPORTED THAT THERE WERE ISSUES WHEN DRAWING BLOOD FROM THE TRANSDUCERS. SPECIFICALLY, BLOOD DRIPS ON THE BLUE PIECE WERE NOTED, DIRECTLY WHERE THE BLOOD COLLECTION ADAPTER IS CONNECTED TO THE SHIELDED BLUNT CANNULA. ALSO, AIR GOING INTO THE ACTUAL BLOOD COLLECTION TUBE WAS NOTED WHEN THIS HAPPENS. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24466424 ↗

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-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-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-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-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-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-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-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-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-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-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-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-0620-05 · Nov 2, 2004 · Terminated
  Angiographic Syringe, 12 cc Palm Pad with Rotator Reservoir.
• Z-0618-05 · Nov 2, 2004 · Terminated
  Angiographic Syringe, 12 cc Thumb Ring with Rotator Reservoir.
• Z-0617-05 · Nov 2, 2004 · Terminated
  Angiographic Syringe, 10 cc Thumb Ring with Rotator Reservoir.

…and 1 more.