INOmax DSIR Plus MRI 10074Recalls & reported problems
Mallinckrodt Manufacturing LLC · INOmax DSIR Plus MRI · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00867538000113), received between Apr 25, 2019 and Jun 29, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Display or Visual Feedback Problem1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2026Loose or Intermittent Connection
A CUSTOMER LOCATED IN THE UNITED STATES CONTACTED KEENOVA ON (B)(6) 2026 TO REPORT THE INJECTOR MODULE RECEPTACLE WAS DAMAGED ON THEIR INOMAX DSIR PLUS DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE COMPLAINT DEVICE WAS RETURNED FOR INVESTIGATION. AN INTERNAL EMPLOYEE PERFORMED A SERVICE ORDER REVIEW FOR INOMAX DSIR PLUS (B)(6). PIN 6 OF THE DEVICE'S INJECTOR MODULE (IM) RECEPTACLE CABLE WAS OBSERVED TO BE DAMAGED. IN ADDITION, A SERVICE LOG REVIEW IDENTIFIED A LOW NO ALARM WITH ZERO IM FLOW. THIS SERVICE LOG FINDING MEETS THE CRITERIA OF A REPORTABLE MALFUNCTION AS IT WAS LOCATED AT A USER'S FACILITY AND SET TO ADMINISTER A DOSE OF INHALED NITRIC OXIDE (NO) AT THE TIME OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25653866 ↗MalfunctionApr 25, 2019Display or Visual Feedback Problem
ON (B)(6) 2019, A MALLINCKRODT INTERNAL EMPLOYEE DISCOVERED A DELIVERY FAILURE ALARM DUE TO OVER DELIVERY FOR INOMAX DSIR (B)(4) FROM THE US. THIS SERVICE LOG FINDING MEETS THE CRITERIA OF A REPORTABLE MALFUNCTION. THERE WAS NO COMPLAINT ALLEGED AGAINST THIS DEVICE. THIS MATCH WAS FOUND DURING ROUTINE REVIEW OF PREVENTATIVE MAINTENANCE SERVICE LOGS FROM A DEVICE IN THE US.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8550185 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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