InnoSpire EleganceRecalls & reported problems across all models
Respironics Respiratory Drug Delivery (Uk) Ltd · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 10 models of InnoSpire Elegance by Respironics Respiratory Drug Delivery (Uk) Ltd in the FDA's device registry (GUDID). Together they are named in 41 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2016 and Dec 18, 2025 — classified as 2 injuries, 39 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (18 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 Elegance problems
Device problems
- Electrical /Electronic Property Problem18
- Material Split, Cut or Torn6
- Degraded3
- Failure to Power Up3
- Smoking3
- Thermal Decomposition of Device3
- Device Emits Odor2
- Insufficient Device Problem Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Consequences Or Impact To Patient17
- Low Oxygen Saturation1
- Malaise1
- No Patient Involvement1
- Pneumonia1
- Respiratory Distress1
- Unspecified Respiratory Problem1
InnoSpire Elegance models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- InnoSpire Elegance 00Compressor, air, portable19 reports
- InnoSpire Elegance 00Compressor, air, portable5 reports
- InnoSpire Elegance 00Compressor, air, portable5 reports
- InnoSpire Elegance 00Compressor, air, portable4 reports
- InnoSpire Elegance 00Compressor, air, portable2 reports
- InnoSpire Elegance 00Compressor, air, portable2 reports
- InnoSpire Elegance 00Compressor, air, portable1 report
- InnoSpire Elegance 00Compressor, air, portable1 report
- InnoSpire Elegance 00Compressor, air, portable1 report
- InnoSpire Elegance 00Compressor, air, portable1 report
Recent InnoSpire Elegance adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2025Smoking; Smoking
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN INNOSPIRE ELEGANCE DEVICE WAS PLUGGED IN AND WAS NOT IN USE WHEN THE DEVICE STARTED SMOKING. THE DEVICE WAS PLUGGED INTO THE RECEPTACLE AND THE AC OUTLET. THERE IS NO SMOKE SMELL. THERE WERE NO REPORTS OF MELTING, WARPING OR VOIDS/GAPS IN ENCLOSURE. THERE ARE NO ALLEGATIONS OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 23845541 ↗MalfunctionApr 25, 2025Thermal Decomposition of Device; Device Emits Odor; Smoking; Thermal Decomposition of Device; Device Emits Odor; Smoking
THE MANUFACTURER RECEIVED INFORMATION ALLEGING DREAMSTATION 2 ADV AUTO CPAP DEVICE EMITTED SMOKE AND A SMELLED LIKE BURNT PLASTIC. THE PATIENT REPORTS THE DEVICE CAUGHT FIRE WHEN THE PATIENT WAS USING THE DEVICE. THE PATIENT PLACED THE DEVICE ON THE FLOOR BECAUSE IT VIBRATED, AND THEY STARTED TO SMELL SOMETHING FUNNY. THE PATIENT REPORTS IT SMELLED LIKE BURNT PLASTIC AND NO FLAMES WERE SEEN. THE PATIENT SAW SMOKE COMING FROM INSIDE THE DEVICE. THE BOTTOM OF THE DEVICE AND SIDES ARE WARPED. THE VENTS ON THE SIDE ARE MELTED. THE PATIENT REPORTS USING A SURGE PROTECTOR. 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 21913100 ↗MalfunctionJan 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE ELEGANCE NEBULIZER DEVICE HAD MOLD IN THE DEVICE AND IN THE PATIENT'S TRACHEOSTOMY TUBE. IT WAS ALLEGED THE DEVICE CAUSED NON-SERIOUS INJURIES OF FEELING "UNWELL" ONCE THE PATIENT RESTARTED USING THE DEVICE. THE PATIENT REPORTED HAVING MEDICAL INTERVENTION OF "SPUTUM CULTURE, CHANGED TRACH TUBE, INCREASED CHEST PHYSIO TO CLEAR THE SPUTUM LOAD, AND WAS GIVEN A NEBULIZER VIA WARD DEVICE". THE MANUFACTURER'S INVESTIGATION IS ONGOING. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: Malaise
MAUDE report 21118498 ↗MalfunctionDec 29, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF ELEGANCE WITH SSR THAT THE PATIENT ALLEGES THAT THE DEVICE DOES NOT GENERATE MIST. 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 18416971 ↗MalfunctionNov 21, 2023Thermal Decomposition of Device; Thermal Decomposition of Device
THE MANUFACTURER BECAME AWARE OF AN ALLEGATION THAT AN INNOSPIRE ELEGANCE DEVICE WITH A STRANGE SMELL AS IF SOMETHING IS BURNING. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. 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 18185496 ↗MalfunctionNov 17, 2023Device Emits Odor; Excessive Heating; Device Emits Odor; Excessive Heating
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO INNOSPIRE ELEGANCE DEVICE. THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE UNIT WAS HOT AND HAD A BURNING SMELL WHILE IN USE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. NO WARPING, MELTING, VOIDS/GAPS, SMOKE, OR FLAMES WERE REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER, AND DURING EVALUATION THE TECHNICIAN WAS UNABLE TO CONFIRM THE THERMAL EVENT. THE DEVICE WAS VISUALLY INSPECTED AND NO SIGNS OF THERMAL OR OTHER EVENTS WERE VISIBLE ON THE PLASTIC PARTS OF THE DEVICE. THE NPC FILTER WAS INSERTED AND DIRTY. THE NEBULIZER WAS CONNECTED TO TEST BENCH WHERE POWER WAS APPLIED AND THE DEVICE POWER'S ON, FAN SPINS, BUT PUMP ENGAGES, LIGHT AMOUNT OF MEDICINE DISPERSING INDICATING LITTLE TO NO PRESSURE. LIGHT ENVIRONMENTAL CONTAMINATION (THE INSIDE OF THE DEVICE APPEARS TO HAVE BEEN RECENTLY CLEANED): DIRT, DUST, AND DEBRIS ATTACHED TO THE FAN AND PUMP ASSEMBLY. NO NOTICEABLE THERMAL OR DAMAGE INSIDE THE DEVICE. UPON DISASSEMBLY OF THE UNIT VERIFYING ONLY LOW PRESSURE AT 1.4 PSI. THERE IS EVIDENCE OF LUBRICANT LEAKAGE, INTERNAL PUMP-CONTAMINATION, AND PISTON-SEAL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18166301 ↗MalfunctionSep 14, 2023Power Problem; Power Problem
THE MANUFACTURER BECAME AWARE OF AN ALLEGATION THAT AN ELEGANCE NEBULIZER HAD A SHORT IN THE POWER CORD. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. 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 17745945 ↗MalfunctionAug 23, 2023Sparking; Noise, Audible; Sparking; Noise, Audible
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A THERMAL EVENT TO AN ELEGANCE NEBULIZER. THE USER ALLEGES THE DEVICE MADE A POPPING NOISE AND PRODUCED A SPARK. THERE WAS NO REPORT OF SMOKE OR FLAMES. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. 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 17602642 ↗MalfunctionApr 19, 2023Thermal Decomposition of Device; Failure to Power Up; Thermal Decomposition of Device; Failure to Power Up
THE MANUFACTURER BECAME AWARE OF AN ALLEGATION THAT AN ELEGANCE NEBULIZER WOULD NOT POWER ON. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE MANUFACTURER RECEIVED THE DEVICE FOR EVALUATION AND COULD CONFIRM THE CUSTOMER'S ALLEGATION THAT THE DEVICE WOULD NOT TURN ON. IN ADDITION, IT WAS DETERMINED THERE WERE BURN MARKS INSIDE THE TOP CASING, THERMAL DAMAGE TO THE MOTOR PLASTIC CASING, AND EXPOSED WIRES DUE TO THERMAL DAMAGE. THIS REPORT WILL BE SUBMITTED AS AN INITIAL FINAL. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NEEDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16772018 ↗MalfunctionJan 6, 2023Failure to Power Up; Failure to Power Up
THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF UNIT HAS LOW FLOW FROM A DME REGARDING AN ELEGANCE NEBULIZER. THERE WAS NO REPORT OF PATIENT HARM OR INJURY, NO REPORT OF EXPOSED WIRES OR THERMAL ISSUES. THE MANUFACTURER RECEIVED THE DEVICE FOR INVESTIGATION. THE UNIT HAS NO POWER, SO WE ARE UNABLE TO CONFIRM THE COMPLAINT OF UNIT HAS LOW FLOW. THE AC POWER CORD HAS A FAULTY PLUG, ONE OF THE PRONGS HAS BROKEN OFF. THERE WAS NO EVIDENCE OF THERMAL DAMAGE, NO VOIDS OR DAMAGE TO THE ENCLOSURES. THERE WERE NO EXPOSED WIRES. THIS REPORT WILL BE SUBMITTED AS AN INITIAL FINAL. THERE WAS NO PATIENT HARM OR INJURY. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NEEDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16113121 ↗MalfunctionJan 6, 2023Failure to Power Up; Failure to Power Up
THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF AN ELEGANCE NEBULIZER THAT WAS NOT TURNING ON. THERE WAS NO PATIENT HARM OR INJURY, NO ALLEGATIONS OF THERMAL DAMAGE, NO VOIDS OR EXPOSED WIRES WERE REPORTED. THE MANUFACTURER RECEIVED THE DEVICE FOR INVESTIGATION AND CONFIRMED THE ALLEGATION OF DEVICE NOT TURNING ON. THERE WAS NO POWER DUE TO DAMAGE TO THE AC POWER CORD. WIRES WERE OUT OF THE STRAIN RELIEF, THE AC POWER CORD HAD EXPOSED COPPER CONDUCTORS. THERE WAS PHYSICAL DAMAGE TO THE CON-ROD, WHICH WAS DETACHED FROM THE COMPRESSOR. THERE WAS NO EVIDENCE OF THERMAL DAMAGE OR VOIDS TO THE ENCLOSURES. THIS REPORT WILL BE SUBMITTED AS AN INITIAL FINAL. THERE WAS NO PATIENT HARM OR INJURY. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NEEDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16112565 ↗MalfunctionAug 24, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION THAT THE BOTTOM OF AN INNOSPIRE ELEGANCE NEBULIZER MELTED. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE MANUFACTURER RECEIVED THE DEVICE FOR EVALUATION AND CONFIRMED THE INITIAL COMPLAINT OF THE BOTTOM OF THE NEBULIZER MELTED. THE DEVICE DID NOT HAVE ANY POWER WHEN PLUGGED IN TO THE AC OUTLET. THE TECHNICIAN VERIFIED THERE WAS THERMAL WARPING, HEAT DISCOLORATION, AND HEAVY FRICTION DAMAGE TO THE BOTTOM ENCLOSURE FROM THE PUMP FAN RUBBING AND CREATING A 2CM VOID. THE THERMAL FUSE BURNED ON THE MOTOR, THEN THE INLINE FUSE OPENED AS DESIGNED, PREVENTING AN ELECTRICAL THERMAL EVENT. THE TECHNICIAN WAS UNABLE TO DUPLICATE THE FAILURE OF THE NEBULIZER DUE TO THE DEVICE NOT HAVING ANY POWER. THIS APPEARS TO POSSIBLY BE CAUSED BY A MOTOR MISALIGNMENT ISSUE WHICH CAUSED THE FAN TO RUB AGAINST THE BOTTOM ENCLOSURE CREATING HEAVY FRICTION AND MOTOR-PUMP DESTABILIZATION WHICH LED TO THE THERMAL EVENT. THIS PRODUCT IS INTENDED TO PROVIDE A SOURCE OF COMPRESSED AIR FOR MEDICAL PURPOSES. IT IS TO BE USED WITH A PNEUMATIC (JET) NEBULIZER TO PRODUCE AEROSOL PARTICLES OF MEDICATION FOR RESPIRATORY THERAPY FOR BOTH CHILDREN AND ADULTS. THIS IS NOT A LIFE SU
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15282745 ↗MalfunctionMar 3, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF BARE WIRES COMING OUT OF ELEGANCE NEBULIZER. THERE WAS NO REPORT OF ANY THERMAL PROBLEMS. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HAS NOT YET RETURNED FOR EVALUATION. THE INVESTIGATION IS ON-GOING. A FOLLOW UP FINAL WILL BE FILED ONCE THE INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13660966 ↗MalfunctionNov 10, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
THE MANUFACTURER RECEIVED THIS DEVICE FOR EVALUATION IN RESPONSE TO A USERS REPORT OF "PHYSICAL DAMAGE". THERE WAS NO PATIENT HARM OR INJURY REPORTED. UPON RECEIPT OF THE DEVICE, THE MANUFACTURER NOTED THE AC CORD PLASTIC OUTER COATING IS SPLIT, EXPOSING WIRES. THE AC CORD WAS TAPED UP. THE REPORTED COMPLAINT OF PHYSICAL DAMAGE WAS CONFIRMED. LABELING WARNS THE "IT IS RECOMMENDED TO HAVE A BACKUP DEVICE FOR RESPIRATORY DELIVERY IN CASE A SITUATION ARISES WHEN YOUR NEBULIZER CAN NOT BE USED". THIS DEVICE MEETS ALL RELEVANT UL AND IEC STANDARDS. THIS DEVICE IS NOT LABELED FOR LIFE SUPPORT. BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12790574 ↗MalfunctionOct 28, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
THE MANUFACTURER RECEIVED THIS DEVICE FOR EVALUATION IN RESPONSE TO A USERS REPORT OF "PHYSICAL DAMAGE". THERE WAS NO PATIENT HARM OR INJURY REPORTED. UPON RECEIPT OF THE DEVICE, THE MANUFACTURER NOTED THE AC CORD PLASTIC OUTER COATING IS SPLIT, EXPOSING WIRES. THE AC CORD WAS TAPED UP. THE REPORTED COMPLAINT OF PHYSICAL DAMAGE WAS CONFIRMED. LABELING WARNS THE "IT IS RECOMMENDED TO HAVE A BACKUP DEVICE FOR RESPIRATORY DELIVERY IN CASE A SITUATION ARISES WHEN YOUR NEBULIZER CAN NOT BE USED". THIS DEVICE MEETS ALL RELEVANT UL AND IEC STANDARDS. THIS DEVICE IS NOT LABELED FOR LIFE SUPPORT. BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12713125 ↗
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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