Boston Scientific recalls AVVIGO+ Multi-Modality Guidance System with incorrect 9-grid overlay in Live mode when using OptiCross 18 catheter. This may cause inaccurate depth settings for peripheral vascular imaging.
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.
Boston Scientific is recalling its AVVIGO+ Multi-Modality Guidance System because a software issue causes it to display a 9-grid overlay instead of the correct 15-grid overlay when used with certain catheters in Live mode. This could lead to inaccurate depth settings for peripheral vascular imaging, potentially affecting medical procedures.
The software anomaly causes the system to show a 9-grid overlay instead of the correct 15-grid overlay when connected to an OptiCross 18 catheter in Live mode. This incorrect display may lead to inaccurate depth settings (14.9mm) for peripheral catheters, but the issue does not affect Review mode or cause physical harm.
Physicians using the AVVIGO+ system with OptiCross 18 Peripheral Imaging Catheters in Live or Record mode. The risk is low as the issue only affects grid overlay display during Live mode and does not cause immediate harm.
Check if your system has the Material Number H7492493221CZ0 or the listed batch/serial numbers. The system uses an interactive display for intravascular ultrasound imaging.
Ensure you are not in Live or Record mode when using the system with OptiCross 18 catheters.
Confirm the system displays a 15-grid overlay for accurate depth settings when using OptiCross 18 catheters in Review mode.
No, the recall is for a software display issue that does not cause physical harm. The risk is low as the problem only affects grid overlay in Live mode and does not impact Review mode.
Check if your system has the Material Number H7492493221CZ0 or the listed batch/serial numbers. The system is safe to use in Review mode but may show incorrect grid overlays in Live mode.
The incorrect grid overlay could lead to inaccurate depth settings (14.9mm) for peripheral catheters, but the system remains safe to use in Review mode. Physicians should verify grid settings when using the system.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0111-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0111-2025 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
