InnoSpire Deluxe 1112279Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 06946159502023), received between Jan 14, 2025 and Feb 25, 2025 — classified as 3 deaths, 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Delivery” (1 report).

1 other recall cover devices cleared under the same FDA submission (K031413); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A UNIT IS LOST AND THAT THE PATIENT HAS PASSED AWAY. THERE WAS NO ALLEGATION OF A SPECIFIC MALFUNCTION OR FAILURE THAT IS RELEVANT TO THE REPORTED DEATH. MEDICAL INTERVENTION WAS NOT SPECIFIED. A PMS CLINICAL EXPERT REVIEW DETERMINED THAT THIS EVENT IS NOT ASSESSABLE FOR INJURY OR RELATEDNESS BASED ON THE INFORMATION PROVIDED AT THIS TIME. 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 21462483 ↗
• MalfunctionJan 31, 2025Inaccurate Delivery; Inaccurate Delivery

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO AN INNOSPIRE DELUXE DEVICE WITH AN ALLEGATION OF DELIVERY ISSUE. 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 21287496 ↗
• DeathJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF DELUXE 230V THAT THE PATIENT ALLEGING DEATH. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. 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 21151500 ↗
• DeathJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF DELUXE 230V 50HZ INT. UK PLUG THAT THE PATIENT ALLEGING DEATH. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. 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 21147413 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031413. One submission often covers many models, so check the product and lot details in each record.

• Z-1720-2015 · Apr 20, 2015 · Terminated
  Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.