AVVIGO™+ H7492493120C0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00191506033125), received between Jun 13, 2025 and Mar 11, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 5, 2024Class IIOpen, Classified

   Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined that, due to a software anomaly, a 9-grid mark overlay is incorrectly displayed during Live mode when AVVIGO+ is connected to an OptiCross 18 Peripheral Imaging Catheter. Note that the correct overlay display for this catheter is the 15-grid mark overlay, which allows for a reference depth setting of 14.9mm for peripheral catheters. This software anomaly is limited to Live or Record mode. In Review mode, the correct 15-grid mark overlay is displayed, and the vessel image is correctly scaled to the appropriate size.

   Z-0109-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionMar 11, 2026Poor Quality Image

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. DURING THE PROCEDURE, AN AVVIGO MULTI-MODALITY GUIDANCE SYSTEM WAS SELECTED FOR USE, THE IMAGE SHOWED UP WAS AFFECTED BY A SNOWFLAKE-LIKE ARTIFACT. THE PROCEDURE WAS CANCELLED DUE TO THE ISSUE PRIOR TO TREATMENT BEING COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570726 ↗
• MalfunctionDec 2, 2025Poor Quality Image; Nonstandard Device; Poor Quality Image; Nonstandard Device

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN AVVIGO MULTI-MODALITY GUIDANCE SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE EQUIPMENT SHOWED A DISTORTED IMAGE WITH ARTIFACTS MAKING ANALYSIS OF THE ARTERY IMPOSSIBLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694763 ↗
• MalfunctionJun 13, 2025Nonstandard Device; Device Displays Incorrect Message; Connection Problem; Material Integrity Problem; Nonstandard Device; Device Displays Incorrect Message; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SYSTEM MISIDENTIFIED THE IMAGING CATHETER. AN AVVIGO PLUS IMAGING SYSTEM WAS SELECTED FOR EXAMINATION OF THE TARGET LESION. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE MOTOR DRIVE UNIT WAS MISREADING CATHETERS, AND THE CATHETERS WERE NOT ABLE TO COMPLETELY LOCK IN. DESPITE THE ISSUE, THE AVVIGO PLUS SYSTEM WAS STILL USED TO MAKE TREATMENT DECISIONS. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY, AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203758 ↗