InnoSpire EssenceRecalls & reported problems across all models
Respironics Respiratory Drug Delivery (Uk) Ltd · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 50
- Deaths reported
- 9
- Injuries reported
- 2
- Recalls
- 0
We found 4 models of InnoSpire Essence by Respironics Respiratory Drug Delivery (Uk) Ltd in the FDA's device registry (GUDID). Together they are named in 50 adverse event reports in the FDA's MAUDE database, received between Apr 27, 2017 and Mar 11, 2026 — classified as 9 deaths, 2 injuries, 39 malfunctions.
The most frequently reported specific device problem is “Degraded” (7 reports).
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
Reports received per month, all models
Most reported InnoSpire Essence problems
Device problems
- Adverse Event Without Identified Device or Use Problem7
- Degraded7
- Electrical /Electronic Property Problem7
- Fire6
- Insufficient Device Problem Information5
- Failure to Deliver4
- Material Split, Cut or Torn4
- Smoking4
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- No Consequences Or Impact To Patient13
- Insufficient Information2
- Patient Problem/Medical Problem1
- Respiratory Distress1
- Respiratory Failure1
InnoSpire Essence models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- InnoSpire Essence 00Compressor, air, portable18 reports
- InnoSpire Essence 00Compressor, air, portable8 deaths13 reports
- InnoSpire Essence 00Compressor, air, portable11 reports
- InnoSpire Essence 00Compressor, air, portable1 death8 reports
Recent InnoSpire Essence adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
DeathMar 11, 2026Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH AN INNOSPIRE ESSENCE NEBULIZER HAS PASSED AWAY. IT WAS ALLEGED THE NEBULIZER WAS DEFECTIVE AND STATED THAT THE DEVICE WAS SUBSEQUENTLY RECALLED. IT IS ALLEGED THAT USE OF THE DEVICE CAUSED OR CONTRIBUTED TO WORSENING OF THE PATIENT¿S RESPIRATORY CONDITION. THE PATIENT SUBSEQUENTLY PASSED ON (B)(6) 2025. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED
Patient problems: Respiratory Failure
MAUDE report 24571611 ↗DeathMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH AN ESSENCE DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE DEVICE IS MISSING AND UNAVAILABLE FOR RETURN TO THE MANUFACTURER FOR INVESTIGATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21593768 ↗DeathFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH AN ESSENCE DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE DEVICE IS MISSING AND UNAVAILABLE FOR RETURN TO THE MANUFACTURER FOR INVESTIGATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21313272 ↗MalfunctionNov 13, 2024Overheating of Device; Failure to Deliver; Overheating of Device; Failure to Deliver
THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE WILL NOT MIST OR PUSH OUT AIR. IT IS REPORTED THE SIDE OF THE DEVICE'S CASE LOOKS TO BE MELTED BUT NOT DISCOLORED. THE DEVICE WAS PLUGGED INTO THE WALL. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20674589 ↗MalfunctionNov 8, 2024Failure to Power Up; Adverse Event Without Identified Device or Use Problem; Failure to Power Up; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE WAS NOT SWITCHING ON AND NOT DELIVERING THE TREATMENT TO THE PATIENT. IT WAS REPORTED THAT TROUBLESHOOTING WAS DONE THE DEVICE WAS PLUGGED INTO POWER, TUBING WAS FIXED AND THEN THE DEVICE WAS TRIED AGAIN. THE EVENT OCCURRED ONCE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20646591 ↗DeathSep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH AN INNOSPIRE ESSENCE DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE DEVICE IS MISSING AND UNAVAILABLE FOR RETURN TO THE MANUFACTURER FOR INVESTIGATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20311138 ↗DeathSep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A ESSENCE RENTAL WITH SSD 230 DEVICE. THE PATIENT HAS ALLEGEDLY PASSED AWAY. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 20311002 ↗DeathSep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO AN ESSENCE DEVICE. THERE WAS AN ALLEGATION OF PATIENT PASSING AWAY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: Insufficient Information
MAUDE report 20306276 ↗MalfunctionJul 23, 2024Failure to Power Up; Smoking; Failure to Power Up; Smoking
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO AN ASSAY FOR ESSENCE PLUG DEVICE WITH ALLEGATION OF DEVICE IS SMOKING AND NOT TURNING ON. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19804822 ↗DeathJun 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH AN INNOSPIRE ESSENCE DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH. THE DEVICE IS MISSING AND UNAVAILABLE FOR RETURN TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19480987 ↗DeathJun 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH AN INNOSPIRE ESSENCE DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH. THE DEVICE IS MISSING AND UNAVAILABLE FOR RETURN TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19480514 ↗DeathJun 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH AN INNOSPIRE ESSENCE DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH. THE DEVICE IS MISSING AND UNAVAILABLE FOR RETURN TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19480350 ↗MalfunctionMay 2, 2024Failure to Deliver; Failure to Deliver
THE MANUFACTURER BECAME AWARE OF A USER OF AN ESSENCE NEBULIZER ALLEGING THAT MEDICATION WAS NOT COMING OUT OF THE DEVICE. THE PATIENT STATES THAT THEY RECENTLY REPLACED THE FILTER AND CLEANED THE PARTS FOLLOWING THE INSTRUCTIONS. THERE WAS NO REPORT OF SERIOUS HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19230935 ↗MalfunctionMar 22, 2024Fire; Fire
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A ESSENCE WITH SSD & SSR DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED CORD CAUGHT ON FIRE AND BURNING SMELL WAS OBSERVED WITHIN THE DEVICE. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18964757 ↗MalfunctionJan 31, 2024Failure to Deliver; Failure to Deliver
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO AN INNOSPIRE ESSENCE DEVICE. THE REPORTER STATED THE LIQUID (MEDICATION) IN THE DEVICE WOULD NOT CONVERT TO MIST. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18620049 ↗
Other Respironics Respiratory Drug Delivery (Uk) Ltd products
All Respironics Respiratory Drug Delivery (Uk) Ltd devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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