ICU Medical 46100-91Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00840619070601), received between Apr 29, 2021 and Jun 14, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K932141); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CATH LAB W/5 PORT "OFF" MANIFOLD (600 PSI), 72" ADMIN SET, AND 4 FT TRANSPAC® IV EXPERIENCED A LOOSE CONNECTION THAT RESULTED IN A LEAK DURING USE. THE REPORT STATED THAT THE PROBLEM, RECENTLY, HAS BEEN WITH THE CONNECTION OF THE TRANSDUCER ON THE LEFT TO THE MANIFOLD. EITHER THE CONNECTION IS NOT TIGHT CAUSING FLUID TO SPRAY OR FLOW OUT. THE TRANSDUCERS WERE NOT CONNECTED TO OTHER DEVICES WHEN THE ISSUE HAPPENED. THE DEVICE WAS FLUSHED WITH HEPARINIZED SALINE. UNABLE TO SEND PICTURES THAT WILL DEFINE THE PROBLEM. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19534632 ↗
• MalfunctionJun 10, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A CATH LAB W/5 PORT "OFF" MANIFOLD (600 PSI), 72" ADMIN SET AND 4 FT TRANSPAC® IV WHERE THE CUSTOMER REPORTED THAT THEY HAD ISSUES WITH THE CONNECTION OF THE TRANSDUCER ON THE LEFT TO THE MANIFOLD; TRANSDUCER ON THE LEFT WAS CRACKED CAUSING FLUID TO SPRAY OR FLOW OUT. THE TRANSDUCERS WERE NOT CONNECTED TO OTHER DEVICE WHEN THE INCIDENT HAPPENED. THE DEVICE WAS FLUSHED WITH HEPARINIZED SALINE. THERE WAS UNKNOWN PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19504886 ↗
• MalfunctionMay 24, 2024Crack; Crack

  THE EVENT INVOLVED A CATH LAB W/5 PORT "OFF" MANIFOLD (600 PSI), 72" ADMIN SET AND 4 FT TRANSPAC® IV WHERE IT WAS REPORTED THAT THE MANIFOLD WAS CRACKED. THE EVENT OCCURRED IMMEDIATELY ON USE IN THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392226 ↗
• MalfunctionMay 24, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT INVOLVED A CATH LAB W/5 PORT "OFF" MANIFOLD (600 PSI), 72" ADMIN SET AND 4 FT TRANSPAC® IV. IT WAS REPORTED THE TRANSUCER WAS LEAKING AND CONNECTIONS ARE NOT SECURING. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ INJURY. ADDTIONALLY IT WAS STATED WHEN SETTING UP THESE 5 PORT MANIFOLDS THEY USE HEPARINIZED SALINE TO FLUSH THEM AND ZERO THEM BEFORE THE CASE. THE TRANSDUCERS WERE NOT CONNECTED TO OTHER DEVICES WHEN ISSUE HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390511 ↗
• MalfunctionMay 19, 2024Crack; Crack

  THE COMPLAINT/EVENT INVOLVED A CATH LAB W/5 PORT "OFF" MANIFOLD (600 PSI), 72" ADMIN SET AND 4 FT TRANSPAC® IV. THE REPORTER STATED THAT THE STOPCOCK CRACKED OFF IMMEDIATELY UPON PATIENT USE AT THE HOSPITAL. THERE WAS NO PATIENT HARM/INJURY AS A RESULT OF THE COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19348477 ↗
• MalfunctionMay 15, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A CATH LAB W/5 PORT "OFF" MANIFOLD (600 PSI), 72" ADMIN SET, AND 4 FT TRANSPAC® IV, WAS FOUND TO HAVE A LOOSE CONNECTION WHICH LED TO A LEAK. THE REPORT STATED THAT THE SET WAS LEAKING, AND CONNECTIONS NOT SECURED. THERE WERE BROKEN SETS AT CONNECTION JOINTS. THE SET DOESN¿T STAY ATTACHED TO THE TUBING. THE EVENT OCCURRED WHEN IT WAS IMMEDIATELY IN USE AT THE HOSPITAL. THE SAMPLE PRODUCT IS AVAILABLE FOR EVALUATION. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19327722 ↗
• MalfunctionMay 15, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT A CATH LAB W/5 PORT "OFF" MANIFOLD (600 PSI), 72" ADMIN SET, AND 4 FT TRANSPAC® IV DISCONNECTED DURING PATIENT USE. THE REPORT STATED THAT THE TRANSDUCER WAS LOOSE AND WON'T TIGHTEN. THE SET WAS LEAKING AND CONNECTIONS WERE NOT SECURED. IN ADDITION, WHEN SETTING UP 5 PORT MANIFOLDS THEY USE HEPARINIZED SALINE TO FLUSH THEM AND ZERO THEM BEFORE THE CASE. THE TRANSDUCERS WERE NOT CONNECTED TO OTHER DEVICES WHEN THE ISSUE HAPPENED. THEY ARE UNABLE TO SEND PICTURES THAT WILL DEFINE THE PROBLEM. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19327673 ↗
• MalfunctionMay 15, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT A CATH LAB W/5 PORT "OFF" MANIFOLD (600 PSI), 72" ADMIN SET, AND 4 FT TRANSPAC® IV DISCONNECTED DURING PATIENT USE. THE REPORT STATED THAT THE TRANSDUCER WAS LOOSE AND WON'T TIGHTEN. THE SET WAS LEAKING AND CONNECTIONS WERE NOT SECURED. IN ADDITION, WHEN SETTING UP 5 PORT MANIFOLDS THEY USE HEPARINIZED SALINE TO FLUSH THEM AND ZERO THEM BEFORE THE CASE. THE TRANSDUCERS WERE NOT CONNECTED TO OTHER DEVICES WHEN THE ISSUE HAPPENED. THEY ARE UNABLE TO SEND PICTURES THAT WILL DEFINE THE PROBLEM. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19327670 ↗
• MalfunctionMay 14, 2024Crack; Disconnection; Fluid/Blood Leak; Crack; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CATH LAB W/5 PORT "OFF" MANIFOLD (600 PSI), 72" ADMIN SET AND 4 FT TRANSPAC® IV, WHERE IT WAS REPORTED THAT THE SET WAS LEAKING, CONNECTIONS NOT SECURING. THERE WERE BROKEN SETS AT CONNECTION JOINTS. THE SET DOESN¿T STAY ATTACHED TO THE TUBING. THE EVENT OCCURRED WHEN IT WAS IMMEDIATELY ON USE AT THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT AND NO INJURY. THIS REPORT CAPTURES 5 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310558 ↗
• MalfunctionFeb 2, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A CATH LAB W/5 PORT "OFF" MANIFOLD (600 PSI), 72" ADMIN SET AND 4 FT TRANSPAC® IV WHERE THE CUSTOMER REPORTED THAT A SET WAS LEAKING AND CONNECTIONS WERE NOT SECURE. THE CUSTOMER FURTHER STATED THAT THE PRODUCTS WERE CRACKED, AND FLUID SPRAYED OUT THE SIDE OF THE CONNECTION TO TRANSDUCER WHEN CONNECTED TO PRESSURE AND FLUID. THERE WAS PATIENT INVOLVEMENT BUT NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT. THIS IS REPORT TWO OF TWO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18634007 ↗
• MalfunctionFeb 2, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A CATH LAB W/5 PORT "OFF" MANIFOLD (600 PSI), 72" ADMIN SET AND 4 FT TRANSPAC® IV WHERE THE CUSTOMER REPORTED THAT A SET WAS LEAKING AND CONNECTIONS WERE NOT SECURE. THE CUSTOMER FURTHER STATED THAT THE PRODUCTS WERE CRACKED, AND FLUID SPRAYED OUT THE SIDE OF THE CONNECTION TO TRANSDUCER WHEN CONNECTED TO PRESSURE AND FLUID. THERE WAS PATIENT INVOLVEMENT BUT NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT. THIS IS REPORT ONE OF TWO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632865 ↗
• MalfunctionJan 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CATH LAB W/5 PORT "OFF" MANIFOLD (600 PSI), 72" ADMIN SET AND 4 FT TRANSPAC® IV. IT WAS REPORTED THERE WAS A SET LEAKING AND CONNECTIONS WERE NOT SECURE. THE PRODUCTS WERE NOTED TO HAVE TRANSDUCERS WHICH WOULD NOT STAY SECURED TO 5 PORT MANIFOLD AND FLUID WOULD LEAK AROUND HAVING TO SWITCH OUT THE TRANSDUCERS FOR NEW THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT OR HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608619 ↗
• MalfunctionApr 29, 2021Inaccurate Information; Inaccurate Information

  THE EVENT INVOLVED CATH LAB W/5 PORT "OFF" MANIFOLD (600 PSI), 72" ADMIN SET AND 4 FT TRANSPAC® IV IN WHICH THE CUSTOMER REPORTED, THAT ON AN UNSPECIFIED DATE, WHEN THEY CONNECT THE FLUID LINE TO PRESSURE, THE TRANSDUCER POPS OFF OR DRIPS. THE CONNECTION IS LOOSE AND WILL NOT TIGHTEN; THE PRESSURES ARE NOT ACCURATE. THE CUSTOMER REMOVES THE TRANSDUCER AND REPLACES WITH A NEW ONE THAT HAS A SHORTER CABLE AND THEY HAVE TO CUT THROUGH THE DRAPE AND COVERING WITH TEGADERM. THEN PATIENT CARE RESUMES. THERE WAS NO MEDICATION INVOLVED IN THIS EVENT. THERE WAS PATIENT INVOLVEMENT, HOWEVER, THERE IS NO ADVERSE EVENT REPORTED AS A CONSEQUENCE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744413 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932141. One submission often covers many models, so check the product and lot details in each record.

• Z-0621-05 · Nov 2, 2004 · Terminated
  Catheterization Kits containing Angiographic Syringes with rotator connector.