Medline RTACIBOMYRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10197344066018), received between Sep 18, 2026 and Sep 23, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 23, 2026Detachment of Device or Device Component

  It was reported that the section where the regulator is changed from intermittent to consistent has broken.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870454 ↗
• MalfunctionSep 18, 2026Break; Crack

  It was reported that the bottom connection where suction comes out has broken off.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50822706 ↗