Boston Scientific recalls AVVIGO+ Multi-Modality Guidance System with incorrect 9-grid overlay in Live mode when used with OptiCross 18 catheter. This 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 issue causes it to display a 9-grid overlay instead of the correct 15-grid overlay when used with an OptiCross 18 catheter 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 an OptiCross 18 catheter in Live or Record mode. This error may cause incorrect depth settings for peripheral vascular imaging, potentially affecting procedure accuracy. However, the error does not occur in Review mode and the system functions correctly for other catheter types.
Physicians using the AVVIGO+ system with OptiCross 18 catheters for vascular imaging procedures are most at risk. The recall affects specific model numbers and batch/serial numbers listed in the notice.
Check if your system has the model numbers H7492493220IZ0 or the batch/serial numbers 102929196, 102929197, 103224212, 103900781, 103900804. The system is sold in Japan with a zero-cost program.
Verify if your system displays a 9-grid overlay when connected to an OptiCross 18 catheter in Live or Record mode.
Boston Scientific identified a software anomaly causing the system to display a 9-grid overlay instead of the correct 15-grid overlay when used with an OptiCross 18 catheter in Live or Record mode.
No, the issue is specific to OptiCross 18 Peripheral Imaging Catheters when used with the AVVIGO+ system in Live or Record mode.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0096-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0096-2025 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.
