TIDI CFI-655Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00618125140428), received between Aug 8, 2025 and Dec 30, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Material Separation; Material Separation

  SUPPLEMENTAL MEDWATCH BEING SENT FOR ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23930853 ↗
• MalfunctionDec 15, 2025Material Puncture/Hole; Material Split, Cut or Torn

  C-ARM DRAPE IMMEDIATELY RIPPED OPEN UPON APPLYING IT TO C-ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802860 ↗
• MalfunctionAug 8, 2025Material Separation; Material Separation

  CUSTOMER REPORTED ITEM# CFI-655 COMES APART DURING DRAPING OR WHEN REPOSITIONING THE C-ARMOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751878 ↗