MIDAS REX MR8 MR8-AF01R (UDI 00763000440992)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000440992), received between Sep 15, 2026 and Sep 15, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (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 16, 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.

• MalfunctionSep 15, 2026Naturally Worn

  It was reported that during maintenance, the attachment was broken. No patient involvement and impact was reported. Additional information was received stating that detached bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50769382 ↗