NAMIC 60131831Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10193489047097), received between Sep 30, 2026 and Sep 30, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionSep 30, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951363 ↗
• MalfunctionSep 30, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950791 ↗
• MalfunctionSep 30, 2026Detachment of Device or Device Component

  It was reported that "Two Manifolds broke during a power injection."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946320 ↗