INOmax DSIR Plus 10007Recalls & reported problems

Summary

The FDA's MAUDE database contains 713 adverse event reports that list this exact device (DI 00867538000106), received between May 5, 2016 and Sep 28, 2026 — classified as 3 deaths, 7 injuries, 703 malfunctions.

The most frequently reported specific device problem is “High Readings” (196 reports).

4 other recalls cover devices cleared under the same FDA submission (K131686); 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 25 most recent of 713 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Intermittent Communication Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922069 ↗
• MalfunctionJun 19, 2026Failure to Recalibrate; High Readings

  DURING A ROUTINE SERVICE LOG REVIEW FOR A DEVICE LOCATED IN THE UNITED STATES, AN INTERNAL EMPLOYEE DISCOVERED THAT A DELIVERY STOPPED ALARM HAD OCCURRED DUE TO A NITRIC OXIDE (NO) CONCENTRATION GREATER THAN 100 PPM FOLLOWED BY A FAILED LOW NO SENSOR CALIBRATION. THIS SERVICE LOG FINDING MEETS THE CRITERIA OF A REPORTABLE MALFUNCTION. THERE WAS NO DELIVERY STOPPED ALARM COMPLAINT OR REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25563346 ↗
• MalfunctionJun 12, 2026Failure to Recalibrate; High Readings

  DURING A ROUTINE SERVICE LOG REVIEW FOR A DEVICE LOCATED IN THE UNITED STATES, AN INTERNAL EMPLOYEE DISCOVERED THAT A DELIVERY STOPPED ALARM HAD OCCURRED DUE TO A NITRIC OXIDE (NO) CONCENTRATION GREATER THAN 100 PPM FOLLOWED BY A FAILED LOW NO SENSOR CALIBRATION. THIS SERVICE LOG FINDING MEETS THE CRITERIA OF A REPORTABLE MALFUNCTION. THERE WAS NO DELIVERY STOPPED ALARM COMPLAINT OR REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25485146 ↗
• MalfunctionJun 10, 2026Intermittent Communication Failure

  A CUSTOMER LOCATED IN THE UNITED STATES CONTACTED KEENOVA ON 28 APR 2026 TO REPORT THEY EXPERIENCED A DELIVERY FAILURE ALARM WITH THEIR INOMAX DSIR PLUS DEVICE WHILE PERFORMING A MONTHLY HIGH RANGE CALIBRATION. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE COMPLAINT DEVICE WAS RETURNED FOR INVESTIGATION. DURING A ROUTINE SERVICE LOG REVIEW, A KEENOVA EMPLOYEE DISCOVERED THAT A DELIVERY FAILURE ALARM HAD OCCURRED DUE TO AN APPARENT INTER-PROCESSOR LINK (IPL) FAILURE. 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 25460880 ↗
• MalfunctionJun 1, 2026Failure to Recalibrate; High Readings

  DURING A ROUTINE SERVICE LOG REVIEW FOR A DEVICE LOCATED IN CANADA, AN INTERNAL EMPLOYEE DISCOVERED THAT A DELIVERY STOPPED ALARM HAD OCCURRED DUE TO A NITRIC OXIDE (NO) CONCENTRATION GREATER THAN 100 PPM FOLLOWED BY A FAILED LOW NO SENSOR CALIBRATION. THIS SERVICE LOG FINDING MEETS THE CRITERIA OF A REPORTABLE MALFUNCTION. THERE WAS NO DELIVERY STOPPED ALARM COMPLAINT OR REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25348237 ↗
• MalfunctionMay 29, 2026Gas/Air Leak

  A CUSTOMER LOCATED IN THE UNITED STATES CONTACTED KEENOVA ON (B)(6) 2026 TO REPORT THEY EXPERIENCED A NO / N2 SYSTEM LEAK WITH THEIR INOMAX DSIR PLUS DEVICE WHILE PERFORMING A HIGH PRESSURE LEAK TEST. 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 (B)(6). REVIEW OF THE SERVICE ORDER DETERMINED THAT THE NO / N2 SYSTEM LEAK WAS CAUSED BY A SHUTOFF VALVE FAILURE. AS A RESULT, THESE SERVICE ORDER FINDINGS MEET 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 INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25336623 ↗
• MalfunctionMay 11, 2026Failure to Deliver

  A CUSTOMER LOCATED IN THE UNITED STATES CONTACTED (B)(6) ON (B)(6) 2026 TO REPORT THEY EXPERIENCED A DELIVERY FAILURE WITH THEIR INOMAX DSIR PLUS DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE COMPLAINT DEVICE WAS RETURNED TO (B)(6) FOR INVESTIGATION. DURING A ROUTINE SERVICE LOG REVIEW, A (B)(6) EMPLOYEE DISCOVERED THAT A DELIVERY FAILURE ALARM HAD OCCURRED DUE TO A MAIN SUPPLY VOLTAGE BELOW TOLERANCE. FURTHER REVIEW OF THE SERVICE LOG DETERMINED THAT A LOW BATTERY ALARM DID NOT OCCUR PRIOR TO THE DELIVERY FAILURE ALARM. AS A RESULT, THESE SERVICE LOG FINDINGS MEET THE CRITERIA OF A REPORTABLE MALFUNCTION AS IT WAS LOCATED AT A USER'S FACILITY AND SET TO ADMINISTER A DOSE OF INHALED NO AT THE TIME OF THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25138704 ↗
• MalfunctionMay 11, 2026Gas/Air Leak

  A CUSTOMER LOCATED IN THE UNITED STATES CONTACTED (B)(6) ON (B)(6) 2026 TO REPORT THEY EXPERIENCED A NO / N2 SYSTEM LEAK WITH THEIR INOMAX DSIR PLUS DEVICE WHILE A PATIENT WAS RECEIVING INHALED NITRIC OXIDE (NO) THERAPY. THE CUSTOMER IMMEDIATELY UTILIZED THE INOMAX DSIR PLUS DEVICE'S INOBLENDER TO MANUALLY VENTILATE THE PATIENT AND THEN REPLACED THE DSIR PLUS WITH A BACKUP UNIT. THE CUSTOMER REPORTED THE PATIENT REMAINED IN STABLE CONDITION AT THE TIME OF THE EVENT. THE COMPLAINT DEVICE WAS RETURNED TO (B)(6) FOR INVESTIGATION. AN INTERNAL EMPLOYEE PERFORMED A SERVICE ORDER REVIEW FOR INOMAX DSIR (B)(6). REVIEW OF THE SERVICE ORDER DETERMINED THAT THE NO / N2 SYSTEM LEAK WAS CAUSED BY A SHUTOFF VALVE FAILURE. AS A RESULT, THESE SERVICE ORDER FINDINGS MEET 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 INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135541 ↗
• MalfunctionMay 4, 2026Intermittent Communication Failure

  A DELIVERY FAILURE ALARM DUE TO AN APPARENT INTER-PROCESSOR LINK (IPL) FAILURE WAS IDENTIFIED BY AN INTERNAL EMPLOYEE DURING A ROUTINE SERVICE LOG REVIEW. 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. THIS DEVICE WAS LOCATED IN THE UNITED STATES WHEN THE REPORTABLE MALFUNCTION OCCURRED. THERE WAS NO DELIVERY FAILURE ALARM COMPLAINT OR REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073065 ↗
• MalfunctionMay 1, 2026Inaccurate Delivery

  DURING A ROUTINE SERVICE LOG REVIEW FOR A DEVICE LOCATED IN THE UNITED STATES, AN INTERNAL EMPLOYEE DISCOVERED THAT A DELIVERY STOPPED ALARM HAD OCCURRED DUE TO A NITRIC OXIDE (NO) CONCENTRATION GREATER THAN 100 PPM FOLLOWED BY AN INJECTOR MODULE FAILURE ALARM FOR TEMPERATURE COUNTS BELOW THE MINIMUM VALID RANGE. THIS SERVICE LOG FINDING MEETS THE CRITERIA OF A REPORTABLE MALFUNCTION. THERE WAS NO DELIVERY STOPPED ALARM COMPLAINT OR REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056240 ↗
• MalfunctionMay 1, 2026Loose or Intermittent Connection

  AN INTERNAL EMPLOYEE PERFORMED A SERVICE ORDER REVIEW FOR INOMAX DSIR PLUS (B)(6). PIN 5 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. TOGETHER, THESE FINDINGS MEET THE CRITERIA OF A REPORTABLE MALFUNCTION. THIS REPORTABLE MALFUNCTION WAS IDENTIFIED DURING A ROUTINE REVIEW OF THE SERVICE ORDER AND SERVICE LOG FOR A DEVICE LOCATED IN THE UNITED STATES. THERE WAS NO REPORTED COMPLAINT OF PHYSICAL DAMAGE TO THE IM RECEPTACLE CABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055877 ↗
• MalfunctionMay 1, 2026Failure to Recalibrate; High Readings

  DURING A ROUTINE SERVICE LOG REVIEW FOR A DEVICE LOCATED IN THE UNITED STATES, AN INTERNAL EMPLOYEE DISCOVERED THAT A DELIVERY STOPPED ALARM HAD OCCURRED DUE TO A NITRIC OXIDE (NO) CONCENTRATION GREATER THAN 100 PPM FOLLOWED BY A FAILED LOW NO SENSOR CALIBRATION. THIS SERVICE LOG FINDING MEETS THE CRITERIA OF A REPORTABLE MALFUNCTION. THERE WAS NO DELIVERY STOPPED ALARM COMPLAINT OR REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055595 ↗
• MalfunctionApr 8, 2026Gas/Air Leak

  A CUSTOMER LOCATED IN THE UNITED STATES CONTACTED KEENOVA ON (B)(6) 2026 TO REPORT THEY EXPERIENCED A NO / N2 SYSTEM LEAK WITH THEIR INOMAX DSIR PLUS DEVICE WHILE PERFORMING A PRE-USE CHECKOUT PROCEDURE. 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 (B)(6). REVIEW OF THE SERVICE ORDER DETERMINED THAT THE NO / N2 SYSTEM LEAK WAS CAUSED BY A SHUTOFF VALVE FAILURE. AS A RESULT, THESE SERVICE ORDER FINDINGS MEET 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 INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821158 ↗
• MalfunctionApr 8, 2026Failure to Deliver

  A DELIVERY FAILURE ALARM DUE TO A MAIN SUPPLY VOLTAGE BELOW TOLERANCE WAS IDENTIFIED BY AN INTERNAL EMPLOYEE DURING A ROUTINE SERVICE LOG REVIEW. FURTHER REVIEW OF THE SERVICE LOG DETERMINED THAT A LOW BATTERY ALARM DID NOT OCCUR PRIOR TO THE DELIVERY FAILURE ALARM. AS A RESULT, THESE SERVICE LOG FINDINGS MEET 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 INCIDENT. THIS DEVICE WAS LOCATED IN THE UNITED STATES WHEN THE REPORTABLE MALFUNCTION OCCURRED. THERE WAS NO DELIVERY FAILURE ALARM COMPLAINT OR REPORT OF PATIENT HARM ASSOCIATED WITH THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820043 ↗
• MalfunctionMar 23, 2026Intermittent Communication Failure

  A DELIVERY FAILURE ALARM DUE TO AN APPARENT INTER-PROCESSOR LINK (IPL) FAILURE WAS IDENTIFIED BY AN INTERNAL EMPLOYEE DURING A ROUTINE SERVICE LOG REVIEW. 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. THIS DEVICE WAS LOCATED IN THE UNITED STATES WHEN THE REPORTABLE MALFUNCTION OCCURRED. THERE WAS NO DELIVERY FAILURE ALARM COMPLAINT OR REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664324 ↗
• MalfunctionMar 23, 2026Failure to Recalibrate; High Readings

  DURING A ROUTINE SERVICE LOG REVIEW FOR A DEVICE LOCATED IN THE UNITED STATES, AN INTERNAL EMPLOYEE DISCOVERED THAT A DELIVERY STOPPED ALARM HAD OCCURRED DUE TO A NITRIC OXIDE (NO) CONCENTRATION GREATER THAN 100 PPM FOLLOWED BY A FAILED LOW NO SENSOR CALIBRATION. THIS SERVICE LOG FINDING MEETS THE CRITERIA OF A REPORTABLE MALFUNCTION. THERE WAS NO DELIVERY STOPPED ALARM COMPLAINT OR REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664005 ↗
• MalfunctionMar 12, 2026Failure to Deliver

  A DELIVERY FAILURE ALARM DUE TO A MAIN SUPPLY VOLTAGE BELOW TOLERANCE WAS IDENTIFIED BY AN INTERNAL EMPLOYEE DURING A ROUTINE SERVICE LOG REVIEW. FURTHER REVIEW OF THE SERVICE LOG DETERMINED THAT A LOW BATTERY ALARM DID NOT OCCUR PRIOR TO THE DELIVERY FAILURE ALARM. AS A RESULT, THESE SERVICE LOG FINDINGS MEET 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 INCIDENT. THIS DEVICE WAS LOCATED IN THE UNITED STATES WHEN THE REPORTABLE MALFUNCTION OCCURRED. THERE WAS NO DELIVERY FAILURE ALARM COMPLAINT OR REPORT OF PATIENT HARM ASSOCIATED WITH THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24584144 ↗
• MalfunctionMar 9, 2026Failure to Deliver

  A DELIVERY FAILURE ALARM DUE TO A MAIN SUPPLY VOLTAGE BELOW TOLERANCE WAS IDENTIFIED BY A INTERNAL EMPLOYEE DURING A ROUTINE SERVICE LOG REVIEW. FURTHER REVIEW OF THE SERVICE LOG DETERMINED THAT A LOW BATTERY ALARM DID NOT OCCUR PRIOR TO THE DELIVERY FAILURE ALARM. AS A RESULT, THESE SERVICE LOG FINDINGS MEET 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 INCIDENT. THIS DEVICE WAS LOCATED IN THE UNITED STATES WHEN THE REPORTABLE MALFUNCTION OCCURRED. THERE WAS NO DELIVERY FAILURE ALARM COMPLAINT OR REPORT OF PATIENT HARM ASSOCIATED WITH THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24547572 ↗
• MalfunctionMar 6, 2026Gas/Air Leak

  A CUSTOMER LOCATED IN CANADA CONTACTED KEENOVA ON (B)(6) 2026 TO REPORT THEY EXPERIENCED A NO/N2 SYSTEM LEAK WITH THEIR INOMAX DSIR PLUS DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE COMPLAINT DEVICE WAS RETURNED TO KEENOVA FOR INVESTIGATION. AN INTERNAL EMPLOYEE PERFORMED A SERVICE ORDER REVIEW FOR INOMAX DSIR (B)(6). REVIEW OF THE SERVICE ORDER DETERMINED THAT THE NO/N2 SYSTEM LEAK WAS CAUSED BY A SHUTOFF VALVE FAILURE. AS A RESULT, THESE SERVICE ORDER FINDINGS MEET 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 INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24534811 ↗
• MalfunctionFeb 13, 2026Failure to Deliver

  A CUSTOMER LOCATED IN THE UNITED STATES CONTACTED (B)(6) ON 12-JAN-2026 TO REPORT THEY EXPERIENCED A DELIVERY FAILURE WITH THEIR INOMAX DSIR PLUS DEVICE WHILE A PATIENT WAS RECEIVING INHALED NITRIC OXIDE (NO) THERAPY. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE COMPLAINT DEVICE WAS RETURNED TO KEENOVA FOR INVESTIGATION. AN INTERNAL EMPLOYEE PERFORMED A SERVICE ORDER REVIEW FOR INOMAX DSIR (B)(4). FURTHER REVIEW OF THE SERVICE LOG DETERMINED THAT A LOW BATTERY ALARM DID NOT OCCUR PRIOR TO THE DELIVERY FAILURE ALARM. AS A RESULT, THESE SERVICE LOG FINDINGS MEET 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 INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333636 ↗
• MalfunctionFeb 11, 2026Failure to Recalibrate; High Readings

  DURING A ROUTINE SERVICE LOG REVIEW FOR A DEVICE LOCATED IN MEXICO, AN INTERNAL EMPLOYEE DISCOVERED THAT A DELIVERY STOPPED ALARM HAD OCCURRED DUE TO A NITRIC OXIDE (NO) CONCENTRATION GREATER THAN 100 PPM FOLLOWED BY A FAILED LOW NO SENSOR CALIBRATION. THIS SERVICE LOG FINDING MEETS THE CRITERIA OF A REPORTABLE MALFUNCTION. THERE WAS NO DELIVERY STOPPED ALARM COMPLAINT OR REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315113 ↗
• MalfunctionFeb 3, 2026Gas/Air Leak

  A CUSTOMER LOCATED IN THE UNITED STATES CONTACTED KEENOVA ON 29-DEC-2025 TO REPORT THEY EXPERIENCED A NO / N2 SYSTEM LEAK WITH THEIR INOMAX DSIR PLUS DEVICE WHILE A PATIENT WAS RECEIVING INHALED NITRIC OXIDE (NO) THERAPY. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE COMPLAINT DEVICE WAS RETURNED TO KEENOVA FOR INVESTIGATION. AN INTERNAL EMPLOYEE PERFORMED A SERVICE ORDER REVIEW FOR INOMAX DSIR (B)(6). REVIEW OF THE SERVICE ORDER DETERMINED THAT THE NO / N2 SYSTEM LEAK WAS CAUSED BY A SHUTOFF VALVE FAILURE. AS A RESULT, THESE SERVICE ORDER FINDINGS MEET 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 INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248590 ↗
• MalfunctionJan 30, 2026Intermittent Communication Failure

  A DELIVERY FAILURE ALARM DUE TO AN APPARENT INTER-PROCESSOR LINK (IPL) FAILURE WAS IDENTIFIED BY AN INTERNAL EMPLOYEE DURING A ROUTINE SERVICE LOG REVIEW. 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. THIS DEVICE WAS LOCATED IN THE UNITED STATES WHEN THE REPORTABLE MALFUNCTION OCCURRED. THERE WAS NO DELIVERY FAILURE ALARM COMPLAINT OR REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24226005 ↗
• MalfunctionJan 23, 2026Intermittent Communication Failure

  A DELIVERY FAILURE ALARM DUE TO AN APPARENT INTER-PROCESSOR LINK (IPL) FAILURE WAS IDENTIFIED BY AN INTERNAL EMPLOYEE DURING A ROUTINE SERVICE LOG REVIEW. 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. THIS DEVICE WAS LOCATED IN THE UNITED STATES WHEN THE REPORTABLE MALFUNCTION OCCURRED. THERE WAS NO DELIVERY FAILURE ALARM COMPLAINT OR REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161059 ↗
• MalfunctionJan 5, 2026Failure to Recalibrate; High Readings

  DURING A ROUTINE SERVICE LOG REVIEW FOR A DEVICE LOCATED IN CANADA, AN INTERNAL EMPLOYEE DISCOVERED THAT A DELIVERY STOPPED ALARM HAD OCCURRED DUE TO A NITRIC OXIDE (NO) CONCENTRATION GREATER THAN 100 PPM FOLLOWED BY A FAILED LOW NO SENSOR CALIBRATION. THIS SERVICE LOG FINDING MEETS THE CRITERIA OF A REPORTABLE MALFUNCTION. THERE WAS NO DELIVERY STOPPED ALARM COMPLAINT OR REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957665 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131686. One submission often covers many models, so check the product and lot details in each record.

• Z-2733-2018 · Jul 9, 2018 · Terminated
  Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an accessory to the nitric oxide delivery device which is
• Z-1076-2017 · Nov 21, 2016 · Terminated
  Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOmax DSIR uses a dual-channel design to ensure
• Z-0575-2015 · Oct 17, 2014 · Terminated
  INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of insp
• Z-1528-2014 · Mar 27, 2014 · Terminated
  INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and pr