Boston Scientific recalls AVVIGO+ Multi-Modality Guidance System with incorrect 9-grid overlay in Live mode when used with 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 an OptiCross 18 catheter in Live or Record mode. This could lead to inaccurate depth settings for peripheral vascular imaging procedures.
The software anomaly causes the system to show a 9-grid mark overlay instead of the correct 15-grid overlay when connected to an OptiCross 18 catheter in Live or Record mode. This could lead to inaccurate 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 vascular imaging procedures 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 with Material Number H7492493120DZ0, GTIN/UDI/DI 00191506033156, and Batch/Serial Numbers 102856880, 102994713, 103058232, 103468307, 103542491, or 103638657.
Verify if the system is in Live or Record mode when using the OptiCross 18 catheter.
If the issue occurs, switch to Review mode for accurate 15-grid overlay display.
Boston Scientific found a software anomaly causing 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.
No, the issue only occurs in Live or Record mode. Review mode displays the correct 15-grid overlay.
The incorrect overlay could lead to inaccurate depth settings for peripheral vascular imaging procedures, but the risk is low as the issue does not cause immediate harm.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0105-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0105-2025 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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