Boston Scientific recalls AVVIGO+ Multi-Modality Guidance System for incorrect 9-grid overlay when using OptiCross 18 catheter in Live mode. 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 software anomaly causes the system to display a 9-grid overlay instead of the correct 15-grid overlay when connected to an OptiCross 18 catheter in Live or Record mode. This could lead to incorrect depth settings (14.9mm) for peripheral vascular imaging procedures. However, the issue does not affect Review mode, where the correct overlay is displayed.
Physicians using the AVVIGO+ system with OptiCross 18 catheters in Europe. The risk is low as the issue only affects Live or Record mode, and Review mode shows the correct overlay.
The recalled system has Material Number H7492493321C0, GTIN/UDI/DI 00191506033385, and Batch/Serial Numbers starting with 104159021. It was sold in Europe for use with OptiCross 18 Peripheral Imaging Catheters.
Ensure you are using Review mode to see the correct 15-grid overlay, as Live or Record mode may show the incorrect 9-grid overlay.
No, the issue only occurs in Live or Record mode. Review mode displays the correct 15-grid overlay.
The correct depth setting is 14.9mm, which requires the 15-grid overlay. The 9-grid overlay may lead to incorrect settings.
Check for Material Number H7492493321C0, GTIN/UDI/DI 00191506033385, and Batch/Serial Numbers starting with 104159021, which were sold in Europe.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0114-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0114-2025 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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