Boston Scientific recalls AVVIGO+ Multi-Modality Guidance System with incorrect 9-grid overlay in Live mode when used with OptiCross 18 catheter. This software issue may affect 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 glitch causes it to display a 9-grid overlay instead of the correct 15-grid overlay when used with OptiCross 18 catheters in Live or Record mode. This could lead to incorrect depth settings for peripheral vascular imaging procedures.
The system displays a 9-grid overlay instead of the correct 15-grid overlay when connected to OptiCross 18 catheters in Live or Record mode. This could cause incorrect depth settings for peripheral vascular imaging procedures. However, the issue does not affect Review mode where the correct 15-grid overlay is displayed.
Physicians using the AVVIGO+ system with OptiCross 18 catheters for intravascular ultrasound imaging are affected. The risk is low as the issue only occurs in Live or Record mode and does not affect Review mode.
Check for the product name 'Boston Scientific AVVIGO+ Multi-Modality Guidance System' with Material Number H7492493320I0 or GTIN/UDI/DI 00191506033354. The system uses OptiCross 18 Peripheral Imaging Catheters with the specific batch/serial numbers listed in the recall.
Verify if the system is in Review mode, where the correct 15-grid overlay is displayed and depth settings are accurate.
The recall indicates a software anomaly that may cause incorrect depth settings, but it does not pose a risk of serious injury as the issue only affects Live or Record mode and not Review mode.
The official recall does not specify a remedy, so no action is required beyond checking the system mode.
Look for the Material Number H7492493320I0 or GTIN/UDI/DI 00191506033354, and check if your system uses OptiCross 18 Peripheral Imaging Catheters with the listed batch/serial numbers.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0098-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0098-2025 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.
