ICU Medical 852-011-46106-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840619097295), received between Aug 15, 2023 and Aug 15, 2023 — classified as 1 malfunction.

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. 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.

• MalfunctionAug 15, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT A TRANSPAC IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3ML SQUEEZE FLUSH MACRO DRIP WAS FOUND TO HAVE "FLUID LEAKAGE FOUND FROM THE CONNECTION SITE THAT SHOULD NOT BE SEPARABLE". THE CONNECTION DISLODGED WHEN THE STAFF WAS EXAMINING THE LEAKAGE. THE LEAKAGE WAS OBSERVED DURING THE FIRST FEW MINUTES ON THE PATIENT. THE INVOLVED PRODUCT WAS USED IN ADULT INTENSIVE CARE UNIT (AICU) / E2C2. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548797 ↗

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-0569-2017 · Sep 27, 2016 · Terminated
  Transpac IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device, PT Tubings, 3-Way Stopcocks and Admin Set, Item No. 46114-80 The Transpac Disposable Straight Pressure Transduce
• Z-0573-2017 · Sep 27, 2016 · Terminated
  Expression MR IBP DPT Kit, I/N, Box 20, Item No. 989803194641 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces be
• Z-0421-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV BIFURCATED MONITORING KIT, 72" 2 DISPOSABLE TRANSDUCERS, with 2 STOPCOCKS, 2 3 ml SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42500-19 The Transpac Disposable Strai
• Z-0427-2017 · Sep 27, 2016 · Terminated
  Transpac IV Monitoring Kit, 60", Disposable Transducer, 3 ml Squeeze Flush Device, Macrodrip, Item No. 42584-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an ex
• Z-0493-2017 · Sep 27, 2016 · Terminated
  MONITORING KIT WITH 03ML FLUSH DEVICE FOR UNIV. OF NEW MEXICO, Item No. 46085-50 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer
• Z-0541-2017 · Sep 27, 2016 · Terminated
  Right Heart Cath Lab Kit w/2 Port "OFF" Manifold (600 psi), 72" Spike Set, Transpac IV and 48" HP Tubing, Item No. 46100-87 The Transpac Disposable Straight Pressure Transducer (DS
• Z-0469-2017 · Sep 27, 2016 · Terminated
  ICN TRANSDUCER KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 46065-64 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduc
• Z-0545-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV TRIFURCATED MONITORING KIT 72", 3 DISPOSABLE TRANSDUCERS, 3 3 ML INTRAFLO FLUSHES, MACRODRIP (POLE MOUNT), Item No. 46101-39 The Transpac Disposable Straight Pressure T
• Z-0531-2017 · Sep 27, 2016 · Terminated
  CATH LAB KIT w/4 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE, WASTE BASIN, SHARPSTOP & TP4, Item No. 46098-76 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravasc
• Z-0431-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH, MACRODRIP (POLE MOUNT), Item No. 42587-05 The Transpac Disposable Straight Pressure Transducer (DSPT) i
• Z-0520-2017 · Sep 27, 2016 · Terminated
  CATH LAB KIT w/3 PORT ''ON'' MANIFOLD, WASTE BAG, TP4, SYRINGES & 30 ml BURETTE, Item No. 46096-26 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular p
• Z-0527-2017 · Sep 27, 2016 · Terminated
  SINGLE (1) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item No. 46097-66 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascul
• Z-0423-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42582-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfa
• 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
• Z-0432-2017 · Sep 27, 2016 · Terminated
  TRANSPAC IV MONITORING KIT, NEONATAL, 24", WITH DISPOSABLE TRANSDUCER, 30 ML INTRAFLO FLUSH (INFUSION PUMP), Item No. 42588-05 The Transpac Disposable Straight Pressure Transducer

…and 178 more.