AVVIGO™+ H7492493120I0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00191506033163), received between Nov 26, 2024 and May 7, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Complete Loss of Power” (1 report).

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-0100-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Incorrect Measurement; Output Problem

  IT WAS REPORTED THAT INACCURATE MEASUREMENT OCCURRED. AN AVVIGO PLUS MULTI-MODALITY GUIDANCE SYSTEM WAS SELECTED. DURING THE PROCEDURE, THE MINIMAL LUMEN AREA (MLA) MEASUREMENTS WERE INACCURATE. IT WAS ALSO NOTED THAT THE FRACTIONAL FLOW RESERVE (FFR) AND DIASTOLIC HYPEREMIA-FREE RATIO (DFR) VALUES WERE ABLE TO EQUALIZE BUT DISAPPEARED DURING PULLBACK. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116545 ↗
• MalfunctionFeb 3, 2026Nonstandard Device; Complete Loss of Power

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN AVVIGO MULTI-MODALITY GUIDANCE SYSTEM WAS SELECTED FOR USE. DURING THE CASE THE SYSTEM WOULD NOT "GO LIVE". THE PROCEDURE WAS CANCELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254519 ↗
• MalfunctionNov 20, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TABLE SIDE CONTROLLER WAS SPARKING. OUTSIDE OF A PROCEDURE, IT WAS NOTED THAT THE AVVIGO PLUS SYSTEM TABLE SIDE CONTROLLER HAD VISIBLE SPARKS COMING OFF OF IT. THE HOSPITAL STAFF TURNED OFF POWER TO THE SYSTEM, AND THERE WAS NO INJURY CAUSED BY THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23611477 ↗
• MalfunctionNov 26, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE OPTICROSS CATHETER WAS MISRECOGNIZED. AN OPTICROSS 6HD AND AVVIGO PLUS SYSTEM WERE SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE OPTICROSS 6HD WAS BEING IDENTIFIED AS AN OPTICROSS 18 WHILE IT WAS PLUGGED IN TO THE AVVIGO PLUS MDU. THIS RESULTED IN THE IMAGES NOT BEING TO SCALE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20789547 ↗