Provox Life Go HME 8310Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07331791011399), received between Feb 2, 2026 and Feb 4, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2026Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT CONCERNS AN END USER WHO HAD AN ASTHMA ATTACK WHILE TESTING THE PROVOX LIFE GO HME FOR THE FIRST TIME. IT IS UNKNOWN IF HE SUFFERS FROM ASTHMA IN GENERAL. THE EVENT OCCURRED WHILE HE WAS WITH HIS SLP IN CONSULTATION AT THE HOSPITAL. THE DIAGNOSIS WAS DONE IN THE HOSPITAL WITH A PULMONOLOGIST. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: Dyspnea

  MAUDE report 24259221 ↗
• InjuryFeb 2, 2026Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT CONCERNS AN END USER WHO HAD AN ASTHMA ATTACK WHILE TESTING THE PROVOX LIFE GO HME FOR THE FIRST TIME. IT IS UNKNOWN IF HE SUFFERS FROM ASTHMA IN GENERAL. THE EVENT OCCURRED WHILE HE WAS WITH HIS SLP IN CONSULTATION AT THE HOSPITAL. THE DIAGNOSIS WAS DONE IN THE HOSPITAL WITH A PULMONOLOGIST. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: Dyspnea

  MAUDE report 24240447 ↗