AVVIGO™ Guidance System II H749009881C0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191506015152), received between May 28, 2024 and May 28, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 28, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROCEDURE WAS ABORTED. THE AVVIGO GUIDANCE SYSTEM II WAS SELECTED FOR USE. DURING THE PROCEDURE, AN ERROR OCCURRED, AND SYSTEM FAILED TO START UP. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND WAS RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19411556 ↗