Iradimed 1056Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00856038001027), received between Mar 31, 2022 and Apr 29, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K050301); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2022Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER THE PATIENT WAS MOVED INTO THE MR SCANNER, THE TUBING CONNECTED TO THE INFUSION PUMP WAS LEAKING. THE PATIENT WAS BEING INFUSED WITH NOREPINEPHRINE AND THE LEAK RESULTED IN A REPLACEMENT INFUSION SET NEEDING TO BE INSTALLED. FOLLOWING THE REPLACEMENT OF THE INFUSION SET, THE PATIENT'S BLOOD PRESSURE DROPPED AND A CODE BLUE WAS CALLED. PATIENT'S PULSE RECOVERED, BUT THE MRI WAS ABORTED.

  Patient problems: Cardiac Arrest

  MAUDE report 14253577 ↗
• InjuryMar 31, 2022Crack; Fluid/Blood Leak; Material Puncture/Hole

  MRI ORDERED FOR EVALUATION OF PATIENT'S NEUROLOGICAL STATUS CONCERNING OF ANOXIC BRAIN INJURY IN THE SETTING OF CARDIAC ARREST. MRI STANDARD TUBING THAT WAS BEING USED WITH NOREPINEPHRINE DEVELOPED A LEAK/HOLE/CRACK IN THE TUBING BETWEEN THE PUMP AND PATIENT AFTER GETTING INTO THE MRI ROOM. PATIENT WAS VERY DEPENDENT ON HER MEDICATIONS KEEPING HER BLOOD PRESSURE UP. AFTER LINING UP THE TABLE TO THE SCANNER, NURSE NOTED SMALL LIQUID DRIPS STARTING TO APPEAR ON THE FLOOR. AFTER FOLLOWING/FEELING TUBING, DETERMINED THE OUTSIDE OF THE TUBING WAS WET, BUT NURSE COULD NOT LOCATE THE HOLE. MEDICATION WAS IMMEDIATELY TRANSFERRED TO A DIFFERENT TUBING. TUBING WAS LATER TESTED/FLUSHED LOOKING FOR A HOLE AND ONE WAS FOUND. NO TUBING LEAKS OR BLOOD PRESSURE PROBLEMS PRIOR TO ENTERING MRI ROOM. TUBING WAS FROM GROIN ON TOP OF PATIENT IN FULL VIEW ON TRANSFER INTO MRI ROOM AND WAS NEVER CAUGHT OR PINCHED ANYPLACE. PATIENT'S BLOOD PRESSURE DROPPED DUE TO TUBING CHANGE, SHE WAS SLOW TO RECOVER. SHOWED NO ARRHYTHMIA ON MONITOR BUT LOST HER PULSE. CODE BLUE CALLED, PULSE RECOVERED AFTER 2 MIN OF CPR, 1MG EPINEPHRINE, AND BLOOD PRESSURE MEDS CATCHING UP. MRI WAS ABORTED. BP SOMEWHAT LABILE IN THE PRO

  Patient problems: Diminished Pulse Pressure; Low Blood Pressure/ Hypotension

  MAUDE report 13964403 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050301. One submission often covers many models, so check the product and lot details in each record.

• Z-1310-2023 · Feb 24, 2023 · Open, Classified
  Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
• Z-0446-2013 · Aug 24, 2012 · Terminated
  The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set. Labeling indicates ~10 ml