Iradimed 3883-2Recalls & reported problems
Iradimed Corp. · ipPOD, Invasive Pressure Truwave, 3880 · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00856038001379), received between Mar 25, 2025 and Mar 25, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Full thickness (Third Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 25, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN EVENT INVOLVING A 3883 AN IPPOD. ACCORDING TO THE RADIOLOGY DIRECTOR, THE PATIENT SUFFERED A THIRD-DEGREE BURN THAT REQUIRED TREATMENT WITH TOPICAL MEDICATION. THE PATIENT WAS EVALUATED BY A SURGEON, AND SURGERY OR OTHER MEDICAL INTERVENTION WAS RULED OUT. THE DEVICE IS AVAILABLE FOR EVALUATION.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 21690596 ↗
Other Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) devices
- Rad-97 9738Masimo Corporation · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1 death222 reports
- Xper Flex Cardio Physiomonitoring System Xper Flex Cardio FC2010 REV CPhilips Ds North America LLC · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls1 death42 reports
- Xper Flex Cardio Physiomonitoring System FC 2010Philips Ds North America LLC · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls2 deaths38 reports
- Welch Allyn, Inc. 901058Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls5 reports
- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls3 reports
- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls2 reports
- McKesson Cardiology Hemo 14.0Change Healthcare Canada Company · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)2 recalls2 deaths2 reports
- Change Healthcare Cardiology Hemo 14.2Change Healthcare Canada Company · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2 recalls1 death1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.