Boston Scientific recalls AVVIGO+ Multi-Modality Guidance System due to incorrect 9-grid overlay display when using OptiCross 18 catheter in Live or Record mode. This may affect depth settings for peripheral catheters.
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 show a 9-grid overlay instead of the correct . This could lead to incorrect depth settings for peripheral catheters during procedures.
The software anomaly displays a 9-grid overlay instead of the correct 15-grid overlay when using OptiCross 18 catheters in Live or Record mode. This could lead to incorrect depth settings for peripheral catheters, but the issue does not affect safety during procedures.
Physicians using the AVVIGO+ system with OptiCross 18 catheters in Live or Record mode. The risk is low as the issue only affects depth settings during specific system modes.
Check for the product name 'AVVIGO+ Multi-Modality Guidance System' with Material Number H7492493320D0 and Batch/Serial Numbers starting with 103874922.
Ensure the system is not in Live or Record mode when using OptiCross 18 catheters.
No, the recall is for a software display issue that could affect depth settings but does not pose a safety risk during procedures.
Check if your system has the Material Number H7492493320D0 and Batch/Serial Numbers starting with 103874922. If so, ensure you are not in Live or Record mode when using OptiCross 18 catheters.
No, the issue only occurs with OptiCross 18 Peripheral Imaging Catheters in Live or Record mode.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0106-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0106-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
