InnoSpire Elegance 00 (REF 1102460)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00383730001753), received between Mar 23, 2021 and Mar 23, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (4 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE MANUFACTURER RECEIVED AN INNOSPIRE ELEGANCE DEVICE FOR EVALUATION WITH THE COMPLAINT THAT THE DEVICE WOULD NOT SWITCH ON. THERE WAS NO PATIENT HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, AN ISSUE RELATED TO THE DEVICE'S AC POWER CORD WAS OBSERVED. THERE WAS EVIDENCE OF EXPOSURE TO THE CONDUCTING WIRES. THE MANUFACTURER CONCLUDES THAT THIS EXPOSURE WAS CAUSED BY THE AC POWER CORD BEING EXPOSED TO FORCES BEYOND THE INTENDED DESIGN. THE INNOSPIRE ELEGANCE DEVICE 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 CHILDREN AND ADULTS. 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 REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11554655 ↗
• MalfunctionMar 23, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE MANUFACTURER RECEIVED AN INNOSPIRE ELEGANCE DEVICE FOR EVALUATION WITH THE COMPLAINT THAT THE DEVICE WOULD NOT SWITCH ON. THERE WAS NO PATIENT HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, AN ISSUE RELATED TO THE DEVICE'S AC POWER CORD WAS OBSERVED. THERE WAS EVIDENCE OF EXPOSURE TO THE CONDUCTING WIRES. THE MANUFACTURER CONCLUDES THAT THIS EXPOSURE WAS CAUSED BY THE AC POWER CORD BEING EXPOSED TO FORCES BEYOND THE INTENDED DESIGN. THE INNOSPIRE ELEGANCE DEVICE 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 CHILDREN AND ADULTS. 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 REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11554633 ↗
• MalfunctionMar 23, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE MANUFACTURER RECEIVED AN INNOSPIRE ELEGANCE DEVICE FOR EVALUATION WITH THE COMPLAINT THAT THE DEVICE WOULD NOT SWITCH ON. THERE WAS NO PATIENT HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, AN ISSUE RELATED TO THE DEVICE'S AC POWER CORD WAS OBSERVED. THERE WAS EVIDENCE OF EXPOSURE TO THE CONDUCTING WIRES. THE MANUFACTURER CONCLUDES THAT THIS EXPOSURE WAS CAUSED BY THE AC POWER CORD BEING EXPOSED TO FORCES BEYOND THE INTENDED DESIGN. THE INNOSPIRE ELEGANCE DEVICE 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 CHILDREN AND ADULTS. 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 REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11554603 ↗
• MalfunctionMar 23, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE MANUFACTURER RECEIVED AN INNOSPIRE ELEGANCE DEVICE FOR EVALUATION WITH THE COMPLAINT THAT THE DEVICE WOULD NOT SWITCH ON. THERE WAS NO PATIENT HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, AN ISSUE RELATED TO THE DEVICE'S AC POWER CORD WAS OBSERVED. THERE WAS EVIDENCE OF EXPOSURE TO THE CONDUCTING WIRES. THE MANUFACTURER CONCLUDES THAT THIS EXPOSURE WAS CAUSED BY THE AC POWER CORD BEING EXPOSED TO FORCES BEYOND THE INTENDED DESIGN. THE INNOSPIRE ELEGANCE DEVICE 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 CHILDREN AND ADULTS. 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 REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11554595 ↗