INOmaxRecalls & reported problems across all models

We found 2 models of INOmax by Mallinckrodt Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Mar 27, 2025 and Apr 21, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Low Readings” (3 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

INOmax recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 8, 2023Open, Classified

   The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.

   Z-2450-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported INOmax problems

INOmax models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• INOmax 91346

  Set, Tubing And Support, Ventilator (W Harness)
  1 recall0 reports
• INOmax 10095

  Apparatus, Nitric Oxide Delivery
  3 reports

Recent INOmax adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2025Low Readings; Low Readings

  THE CUSTOMER CONTACTED MALLINCKRODT TO REPORT THEY EXPERIENCED INJECTOR MODULE REVERSE FLOW - HIGH PRIORITY ALARM WITH THEIR INOMAX EVOLVE DS DEVICE WHILE A PATIENT WAS RECEIVING INHALED NITRIC OXIDE (NO) THERAPY. THE CUSTOMER REPORTED THE ADULT PATIENT WAS BEING TRANSITIONED FROM THE HAMILTON G5 VENTILATOR TO THE HAMILTON T1 VENTILATOR IN PREPARATION FOR INTRA-HOSPITAL TRANSPORT. THE CUSTOMER STATED INOMAX THERAPY WAS INITIATED ON (B)(6) 2025, IN CONJUNCTION WITH HAMILTON G5 VENTILATOR WITH A SET NO DOSE OF 20PPM. THE CUSTOMER STATED THAT THE EVOLVE DEVICE WAS FULLY OPERATIONAL WHEN USED IN CONJUNCTION WITH THE HAMILTON G5. HOWEVER, THE CUSTOMER REPORTED SOON AFTER THE PATIENT WAS PLACED ON THE HAMILTON T1 VENTILATOR WITH SETTINGS OF PC-AC, PRESSURE CONTROL OF 14, RESPIRATORY RATE OF 20, PEEP +12, INSPIRATORY TIME OF 0.8 SECONDS, FLOW TRIGGER OF 5 L/MIN, AND FIO2 OF 30%, THE EVOLVE DEVICE ALARMED FOR INJECTOR MODULE REVERSE FLOW. THE CUSTOMER REPORTED THE PATIENT'S OXYGEN SATURATION DECREASED FROM 95% TO 84% AND THE MAP (MEAN ARTERIAL PRESSURE) DECREASED FROM 63 MMHG TO 48 MMHG "IMMEDIATELY". THE CUSTOMER STATED AS SOON AS THE PATIENT DECOMPENSATED, THEY PLACED THE PATIENT BACK ON

  Patient problems: Low Blood Pressure/ Hypotension; Low Oxygen Saturation

  MAUDE report 21877708 ↗
• InjuryApr 21, 2025Low Readings; Low Readings

  THE CUSTOMER CONTACTED MALLINCKRODT TO REPORT THEY EXPERIENCED AN INJECTOR MODULE REVERSE FLOW - HIGH PRIORITY ALARM WITH THEIR INOMAX EVOLVE DS DEVICE WHILE A PATIENT WAS RECEIVING INHALED NITRIC OXIDE (NO) THERAPY. THE PATIENT WAS INITIATED ON INOMAX ON (B)(6) 2025 WITH A SET DOSE OF 20PPM. THE PATIENT WAS VENTILATED USING A MAQUET SERVO-U VENTILATOR IN PC/SIMV MODE WITH A RR40, PC18, PS14, PEEP+7, FIO2 OF 50%. THE BASELINE O2 SATURATION WAS BETWEEN 95% AND 98% VIA PULSE OXIMETRY. THE RETURNED TIDAL VOLUME WAS CONSISTENTLY AT APPROXIMATELY 9ML. THE PATIENT WAS NOT BREATHING ABOVE THE VENTILATOR AT THE TIME. THE CUSTOMER REPORTED THAT WHEN THEY TRANSITIONED THE PATIENT FROM THE INOMAX DSIR PLUS DELIVERY SYSTEM TO THE INOMAX EVOLVE DS WHEN THE INJECTOR MODULE REVERSE FLOW - HIGH PRIORITY ALARM AND LOW NO - ALARM OCCURRED. DURING THIS TIME, THE PATIENT EXPERIENCED OXYGEN DESATURATION, AND THE PATIENT WAS PLACED BACK ONTO THE DSIR PLUS DEVICE THAT HAD REMAINED AT THE BEDSIDE. THE CUSTOMER REPORTED THE PATIENT'S OXYGEN SATURATION DECREASED FROM BASELINE TO A LOW OF 50% DURING THIS EPISODE. THE CUSTOMER REPORTED THE STAFF DID NOT BAG THE PATIENT; HOWEVER, INCREASED THE FIO2 ON THE VENT

  Patient problems: Low Oxygen Saturation

  MAUDE report 21877485 ↗
• InjuryMar 27, 2025Failure to Deliver; Low Readings; Intermittent Communication Failure; Failure to Deliver; Low Readings; Intermittent Communication Failure

  THE CUSTOMER CONTACTED MALLINCKRODT TO REPORT THEY EXPERIENCED A PRIMARY DELIVERY FAILURE ALARM WITH THEIR INOMAX EVOLVE DS DEVICE WHILE A PATIENT WAS RECEIVING INHALED NITRIC OXIDE (NO) THERAPY. THE PATIENT WAS AN ADULT BEING VENTILATED WITH A HAMILTON G5 VENTILATOR WITH THE FOLLOWING VENTILATOR PARAMETERS: VC-CMV, RR 12BPM, VT 220ML, FIO2 40% AND PEEP +5 CM H2O. THE PATIENT WAS RECEIVING INOMAX FOR APPROXIMATELY 12 HOURS WITH A SET DOSE OF 10PPM. THE RESPIRATORY THERAPIST WAS CALLED INTO THE PATIENT'S ROOM FOR A LOW NO ALARM AND UPON ARRIVAL A PRIMARY DELIVERY FAILURE ALARM WAS PRESENT. THE CUSTOMER REPORTED THE PATIENT WAS HYPOTENSIVE WITH BLOOD PRESSURE MONITORED BY ARTERIAL LINE OF 70/40 WITH A MEAN ARTERIAL PRESSURE OF 40MMHG. THE RESPIRATORY THERAPIST REPORTED THEY WERE "UNSURE IF THE EINOBLENDER WOULD STILL WORK" DUE TO THE PRIMARY DELIVERY FAILURE ALARM AND LEFT TO RETRIEVE A REPLACEMENT INOMAX EVOLVE DS. THE CUSTOMER REPORTED THAT ANOTHER HEALTHCARE PROVIDER ARRIVED SHORTLY AFTER AND NOTED THE ALARM, AND THEN IMMEDIATELY ACTIVATED THE EINOBLENDER AT 10PPM AND BEGAN TO VENTILATE THE PATIENT USING THE EINOBLENDER AND A MANUAL RESUSCITATOR BAG. THE PATIENT RESPONDED QUICKLY

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 21710364 ↗