SIMPLYGO SimplyGo, INTL, ITRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959048812), received between May 20, 2026 and May 20, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Overheating of Device

  A SIMPLYGO, INTERNATIONAL, IT DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND THAT THE PCA IS BURNT. SIEVES ARE CLOGGED; THEY HAVE TO BE REPLACED. INLET FILTER WILL BE REPLACED DUE TO PREVENTIVE MAINTENANCE. COMPRESSOR IS DEFECTIVE, IT HAS TO BE REPLACED. TUBING IS CONTAMINATED; IT HAS TO BE REPLACED. CHECK VALVE COVER IS CRACKED, IT HAS TO BE REPLACED. THERE ARE MISSING SCREWS ON THE REAR ENCLOSURE; THEY HAVE TO BE ADDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25237595 ↗