AVVIGO+Recalls & reported problems across all models

We found 5 models of AVVIGO+ by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Nov 26, 2024 and May 7, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (3 reports).

5 FDA recall records name at least one of these models by its device identifier, 5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

AVVIGO+ recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 5, 2024Open, 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-0116-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Sep 5, 2024Open, 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-0113-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Sep 5, 2024Open, 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 ↗

4. Sep 5, 2024Open, 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-0107-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Sep 5, 2024Open, 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 AVVIGO+ problems

AVVIGO+ models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AVVIGO™+ H7492493120I0

  Computer, diagnostic, programmable
  1 recall4 reports
• AVVIGO™+ H7492493120C0

  Transducer, ultrasonic, diagnostic
  1 recall3 reports
• AVVIGO™+ H7492493120D0

  Computer, diagnostic, programmable
  1 recall0 reports
• AVVIGO™+ H7492493121C0

  COMPUTER, BLOOD-PRESSURE
  1 recall0 reports
• AVVIGO™+ H7492493121I0

  Transducer, ultrasonic, diagnostic
  1 recall0 reports

Recent AVVIGO+ adverse event reports

The 7 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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