SimplyGo Mini SimplyGo Mini with Standard Battery, IKKRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00606959033825), received between May 5, 2025 and Feb 3, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Thermal Decomposition of Device

  A SIMPLYGO MINI DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, THE SERVICE OBSERVED THE LOW O2 LEVELS WERE LOW BECAUSE THE MOLECULAR SIEVES WERE CLOGGED. ADDITIONALLY, LEAKS WERE IDENTIFIED ON BOTH THE OXYGEN AND A CIRCUITS. THE COMPRESSOR IS NOT OPERATING WITHIN NORMAL PARAMETERS, AND ITS TUBING IS CONTAMINATED. FURTHERMORE, THE PCA FAILED T START BECAUSE IT IS BURNT OUT, AND THE PATIENT FILTER IS CONTAMINATED. THE DEVICE RETURNED UNREPAIRED. FURTHER THE DEVICE WAS SENT TO PIL FOR FURTHER INVESTIGATION. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250771 ↗
• MalfunctionDec 22, 2025Overheating of Device; Overheating of Device

  A SIMPLYGO MINI DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION AT THE SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND TO HAVE A BURNED PCA BOARD. ADDITIONALLY, THE SIEVES WERE CLOGGED AND REQUIRED REPLACEMENT. BOTH THE AIR SIDE AND OXYGEN SIDE WERE CRACKED AND NEEDED REPLACEMENT, AND THE INLET FILTER REQUIRED REPLACEMENT AS PART OF PREVENTIVE MAINTENANCE. THE THIRD-PARTY SERVICE CENTER WAS UNABLE TO COMPLETE THE INVESTIGATION, AND THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LABORATORY FOR FURTHER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871288 ↗
• MalfunctionNov 14, 2025Overheating of Device; Overheating of Device

  A SIMPLYGO MINI DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER COMPLAINT WAS CONFIRMED. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED THAT THE MAIN PCA WAS BURNED AND NEEDED REPLACEMENT. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WILL BE RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LAB FOR ADDITIONAL TESTING. THE ROOT CAUSE IS NOT CONFIRMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23553786 ↗
• MalfunctionJul 16, 2025Overheating of Device; Overheating of Device

  A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE, THEY FOUND OUT THAT PCA IS BURNT, THE UNIT DOES NOT START, SIEVES ARE CLOGGED, THE AIR SIDE AND O2 SIDE AND COMPRESSOR ARE CONTAMINATED AND NEED TO BE REPLACED. PASS ALL TEST. DEVICE IS RETURNED, REPAIRED. REPORTABLE SINCE DEVICE ISSUE/EVENT HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523683 ↗
• MalfunctionMay 7, 2025Smoking; Smoking

  THE MANUFACTURER WAS CONTACTED ABOUT A SIMPLYGO MINI STAND BATTERY IKK DEVICE DUE TO REPORTS OF IT SMOKING. THE SERVICE CENTER HAS RECEIVED THE DEVICE FOR EVALUATION. IMPORTANTLY, THERE ARE NO CLAIMS OF PATIENT HARM OR SERIOUS INJURY, AND NO MEDICAL INTERVENTION HAS BEEN SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS STILL IN PROGRESS. IF ANY ADDITIONAL RELEVANT INFORMATION COMES IN, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21982161 ↗
• MalfunctionMay 5, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A SIMPLY GO MINI DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER IN REFERENCE TO A REQUEST FOR SERVICING THE SIEVE FILTER. DURING THE INITIAL EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE UNIT AND FOUND THE TOP OF THE ENCLOSURE DENTED AND BURNED. THERE WAS NO ALLEGATION 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 21964476 ↗