Iradimed 3860+Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00856038001089), received between Oct 31, 2018 and Sep 23, 2026 — classified as 1 death, 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (7 reports).

2 other recalls cover devices cleared under the same FDA submission (K090087); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Insufficient Device Problem Information

  It was reported that the customer experienced an event in which the infusion pump shut down during patient transport. According to the Biomedical Engineering Technician, while the patient was being transported into an elevator, the pump displayed alarm codes 129 and 229. At the time of the initial report, no patient harm or serious injury was reported, and no medical intervention to prevent or preclude harm was reported.

  Patient problems: Insufficient Information

  MAUDE report 50863204 ↗
• InjuryNov 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE DISTRIBUTOR THAT THE CUSTOMER EXPERIENCED AN EVENT INVOLVING TWO IRADIMED MRIDIUM INFUSION PUMPS (SAEGELING), SERIAL NUMBERS (B)(6). THE PATIENT, WHO HAD SUFFERED MULTIPLE GENERALIZED SEIZURES DURING THE RECOVERY PHASE, REQUIRED A HEAD MRI. DURING THE EXAMINATION, THE PATIENT WAS SEDATED WITH PROPOFOL ADMINISTERED VIA AN MRIDIUM SYRINGE PUMP (S/N (B)(6)), AND BLOOD PRESSURE WAS SUPPORTED WITH NOREPINEPHRINE VIA A SECOND SYRINGE PUMP OF THE SAME BRAND (S/N (B)(6)). THE NOREPINEPHRINE PUMP WAS SET TO A DOSE OF G/KG/MIN, AND THE PROPOFOL PUMP WAS SET TO MG/KG/H. ARTERIAL BLOOD PRESSURE, HEART RATE, OXYGEN SATURATION (O2), AND END-TIDAL CO2 WERE CONTINUOUSLY MONITORED, WITH THE MONITORING DISPLAYED IN THE MRI CONTROL ROOM. THE PATIENT INITIALLY HAD STABLE HEMODYNAMIC CONDITIONS, AND ANESTHESIA WAS MONITORED REMOTELY FROM THE CONTROL ROOM. DURING THE EXAMINATION, A SUDDEN DROP IN BLOOD PRESSURE OCCURRED. UPON IMMEDIATE ASSESSMENT, IT WAS DISCOVERED THAT THE NOREPINEPHRINE PUMP HAD AUTOMATICALLY CHANGED THE DOSE SETTING FROM 0.06 ¿G/KG/MIN TO 1 ML/H WITHOUT USER INTERVENTION. AT THE END OF THE EXAMINATION, THE PROPOFOL PUMP ALSO AUTOMATICALLY CHANGED ITS DOSING SET

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 23446067 ↗
• InjurySep 12, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DURING AN MRI SCAN, THE ACCOMPANYING NURSE NOTICED THAT THE NEW BOTTLE OF PROPOFOL HAD COMPLETELY EMPTIED WHEN IT WAS CONNECTED TO THE PATIENT'S CENTRAL LINE, EVEN THOUGH THE PUMP APPEARED TO BE WORKING PROPERLY (GREEN LIGHT AND FLOW RATE BETWEEN 5 AND 7 CC/H). THE PATIENT THEREFORE RECEIVED THE ENTIRE BOTTLE OF PROPOFOL (1000 MG).

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 23042329 ↗
• InjuryJul 2, 2025Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method; Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE USER EXPERIENCED A POSSIBLE OVER-INFUSION EVENT. ACCORDING TO THE BIOMED, THE INFUSION PUMP WAS RUNNING NORMALLY WHEN THEY SUDDENLY NOTICED A QUESTION MARK ON THE DISPLAY, AND THE PUMP BEGAN INFUSING AT A FASTER RATE, RESULTING IN AN OVER-INFUSION. ACCORDING TO THE NURSE MANAGER, THE PATIENT DID NOT SUFFER ANY HARM BUT WAS PLACED ON AIRWAY SUPPORT TO PREVENT OR PRECLUDE POTENTIAL HARM.

  Patient problems: Insufficient Information

  MAUDE report 22386656 ↗
• InjuryJun 20, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A POSSIBLE OVER-INFUSION EVENT. ACCORDING TO BIOMED, THE PUMP WAS PROGRAMMED WITH A VTBI OF 77.6 ML. HOWEVER, THE USER NOTICED THAT A FEW MINUTES AFTER STARTING THE INFUSION, THE VOLUME LEFT IN THE RESERVOIR WAS 32.3 ML. BIOMED INSPECTED THE INFUSION PUMP AND OBSERVED THAT THE PUMP INDICATED ONLY 2.2 ML HAD BEEN INFUSED. IT WAS REPORTED THAT THE PATIENT SUFFERED HARM, BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22301533 ↗
• InjuryMay 29, 2025Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method; Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A POTENTIAL OVER-INFUSION EVENT. ACCORDING TO BIOMED, THE INTENDED INFUSION RATE WAS 13.0 ML/HR; HOWEVER, THE INFUSION RATE DURING THE EVENT WAS 130 ML/HR. THE USER STATED THAT THEY WERE USING THE DRUG LIBRARY AND HAD SELECTED PROPOFOL. BIOMED INSPECTED THE PUMP AND COULD NOT REPRODUCE THE INCREASED RATE USING THE DRUG LIBRARY, BUT UPON REVIEWING THE LOG, HE NOTICED THAT THE USER HAD SELECTED "DRUG ?". BIOMED WANTED TO CONFIRM THIS FINDING BY EVALUATING THE HISTORY LOG, AS USER ERROR WAS SUSPECTED. THE PATIENT'S STATUS WAS DESCRIBED AS HAVING "CRASHED DURING THE EVENT" AND REQUIRED MEDICAL INTERVENTION TO PRECLUDE HARM.

  Patient problems: Insufficient Information

  MAUDE report 22107378 ↗
• DeathMay 15, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POTENTIAL UNDER-INFUSION EVENT. ACCORDING TO BIOMED, THE MRI TECHNICIAN OBSERVED A BUBBLE OF AIR IN THE IV LINE. HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING WHETHER ANY ALARMS OCCURRED DURING THE EVENT. PER BIOMED THE PATIENT CODED DURING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22031137 ↗
• InjuryJan 10, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN EVENT IN WHICH THE INFUSION PUMP DELIVERED A LARGE BOLUS TO THE PATIENT AT THE BEGINNING OF THE INFUSION. ACCORDING TO THE BIOMEDICAL ENGINEER, THEY BELIEVED THE EVENT WAS DUE TO USER ERROR AND REQUESTED ASSISTANCE TO DOWNLOAD THE DEVICE HISTORY LOG. THE CUSTOMER CONFIRMED THAT NO PATIENT HARM OCCURRED. HOWEVER, THE PATIENT BECAME AGITATED AND REQUIRED A VENTILATOR.

  Patient problems: Insufficient Information

  MAUDE report 21129928 ↗
• InjuryOct 4, 2024Misassembled During Installation; Misassembled During Installation

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN EVENT IN THE ICU WHERE THE IRADIMED POLE WAS TOO LARGE FOR THEIR ELEVATORS, AND THEY HAD TO REMOVE THE IRADIMED INFUSION PUMP TO TRANSPORT IT DOWN TO THE MRI. UPON ARRIVING AT THE MRI, THEY WERE PROVIDED WITH A NON-MRI SAFE POLE THAT WAS NOT AN IRADIMED POLE. THIS POLE WAS PULLED INTO THE MAGNET, RESULTING IN AN MRI STAFF MEMBER'S ARM BEING BROKEN.

  Patient problems: Bone Fracture(s)

  MAUDE report 20375199 ↗
• InjurySep 25, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN EVENT IN WHICH THE RN PROGRAMMED THE MRI-COMPATIBLE PUMP WITH DUAL RN SIGN-OFF. THE PATIENT WAS TAKEN TO MRI, WHERE A NEW BAG OF HEPARIN WAS STARTED AT 22:06, ALSO WITH DUAL RN SIGN-OFF USING THE MRI-COMPATIBLE PUMP. THE PATIENT REMAINED IN MRI AND WAS BROUGHT BACK TO THE FLOOR AT 22:50. THE RN NOTICED THAT THE NEW BAG OF HEPARIN WAS LESS THAN HALF FULL AFTER ONLY RUNNING FOR ONE HOUR. THE RN PAUSED THE INFUSION, AND A PTT WAS DRAWN. THE PUMP WAS SUPPOSED TO DELIVER 40.55 ML/HR, BUT IT APPEARS THE PATIENT RECEIVED APPROXIMATELY 250 ML WITHIN 50 MINUTES. ALTHOUGH THE FACILITY CONFIRMED THAT NO OBVIOUS HARM WAS NOTED FROM THE EVENT, THEY DID REPORT THAT MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE HARM.

  Patient problems: Insufficient Information

  MAUDE report 20305057 ↗
• InjuryNov 17, 2023

  IRADIMED MRIDIUM 3860+ IV (INTRAVENOUS) PUMP WAS USED TO ADMINISTER CONTINUOUS INFUSION OF DEXMEDETOMIDINE DURING MRI (MAGNETIC RESONANCE IMAGING) SCAN. DURING THE MRI (MAGNETIC RESONANCE IMAGING) SCAN PATIENT CONDITION CHANGED. BRADYCARDIA, HYPOXIA, AND MENTAL STATUS CHANGES OCCURRED. HEART RATE WAS 60 BPM, OXYGEN SATURATION 80% AND GLASGOW COMA SCORE OF 6 (BASELINE GCS 13) RASS (RICHMOND AGITATION-SEDATION SCALE) OF -5. DEXMEDETOMIDINE IV BAG HAD 59 ML OF MEDICATION UNACCOUNTED FOR THAT WAS PRESUMED TO HAVE BEEN INADVERTENTLY ADMINISTERED TO THE PATIENT AS A PUMP "OVER INFUSION". PUMP EVENT LOG WAS REVIEWED BY MED SAFETY AND BIOMEDICAL ENGINEERING STAFF WITH ASSISTANCE OF IRADIMED VICE PRESIDENT OF QUALITY AND REGULATORY (B)(4). EVENT LOG INDICATES A PERIOD WHERE FREE FLOW OF MEDICATION WAS LIKELY. EXAMINATION OF THE IV PUMP IN QUESTION FOUND NO ABNORMALITIES WHEN SUBJECTED TO A PREVENTIVE MAINTENANCE INSPECTION BY BIOMED STAFF. FURTHER ANALYSIS AND RECREATION OF THE CIRCUMSTANCES OF THE EVENT IN QUESTION REVEALED SEVERAL CONCERNS AND FAILURE MODES, NOT LIKELY TO BE IDENTIFIED BY USERS. IN SOME CASES, THE WARNINGS OR ALERTS PRESENTED BY THE DEVICE DO NOT REFLECT THE CAUSE OF THE

  Patient problems: Bradycardia; Cognitive Changes; Hypoxia

  MAUDE report 18173964 ↗
• InjuryMar 13, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED THAT AN EVENT OCCURRED, BUT NO OTHER DETAILS WERE INITIALLY AVAILABLE. ON 02/15/2023 THE HOSPITAL BIOMEDICAL ENGINEER PROVIDED ADDITIONAL INFORMATION THAT BAG VENTILATION FOR APNEA AND LARYNGEAL MASK AIRWAY WERE REQUIRED FOLLOWING THE EVENT, BUT STILL NO FURTHER DETAILS WERE AVAILABLE. ON 02/23/2023 THE HISTORY LOG FILE FROM THE INFUSION PUMP WAS PROVIDED FOR ASSISTANCE IN INTERPRETING THE DATA. THE HISTORY LOG SHOWS THAT ON 02/03/2023 THE USER PROGRAMMED CISATRACURIUM AT A RATE OF 350 MG/KG/HR FOR A 7.7 KG PATIENT. THE CALCULATED RATE FOR THIS DOSE IS 1348 ML/HR BASED ON THE PATIENT SIZE. THE PUMP WAS PROGRAMMED TO INFUSE 23 ML AT THIS RATE WHICH SHOULD TAKE ABOUT 1 MINUTE. THE INFUSION WAS STARTED, AND 51 SECONDS LATER THE PUMP STOPPED WITH AN ALARM FOR PATIENT OCCLUSION. THE USER RESET THE ALARM AND RESTARTED THE PUMP AT THE SAME RATE. A SECOND PATIENT OCCLUSION OCCURRED AND AGAIN THE USER RESET THE ALARM AND RESTARTED THE PUMP. A THIRD OCCLUSION ALARM OCCURRED AND THIS TIME THE USER CHANGED THE PROGRAMMING TO A NEW DRUG, PROPOFOL, AND A NEW RATE OF 150 MCG/KG/MIN WITH A DILUTION OF 10 MG/ML FOR THE SAME 7.7 KG PATIENT. IT IS UNKNOWN IF THE WRONG DRUG WAS INITIAL

  Patient problems: Apnea

  MAUDE report 16531629 ↗
• MalfunctionOct 31, 2018Defective Component

  PATIENT TRANSFERRED WITH KNOWN EMERGENT LARGE VESSEL OCCLUSION (ELVO) FROM OUTSIDE OF HOSPITAL. PATIENT PRESENTED TO MRI FOR HYPERACUTE MRI, RAPID INTUBATED. PATIENT REQUIRED MRI COMPATIBLE PUMP, WHICH WAS MALFUNCTIONING FOR A HALF HOUR, DELAYING THE MRI AND PATIENT'S CARE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8023585 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090087. 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-1874-2013 · Jul 1, 2013 · Terminated
  MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for