Boston Scientific recalls AVVIGO+ Multi-Modality Guidance System with incorrect 9-grid overlay when used with OptiCross 18 catheter in Live/Record mode. 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 system incorrectly 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 could lead to inaccurate depth settings (14.9mm) for peripheral vascular imaging procedures. However, the correct overlay appears in Review mode, so the issue does not affect all usage scenarios.
Physicians using the AVVIGO+ system with OptiCross 18 catheters during 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 name 'AVVIGO+ Multi-Modality Guidance System' with Material Number H7492493320C0 or GTIN/UDI/DI 00191506033309. The affected units have specific batch/serial numbers listed in the recall notice.
Verify if the system is in Live or Record mode when connected to an OptiCross 18 catheter.
If in Live or Record mode, switch to Review mode to ensure the correct 15-grid overlay displays.
No, the issue only affects Live or Record mode and does not cause injury. The correct overlay appears in Review mode.
Check if your system is in Live or Record mode with an OptiCross 18 catheter. If so, switch to Review mode to use the correct overlay. The system is safe for use in Review mode.
Affected units have Material Number H7492493320C0 or GTIN/UDI/DI 00191506033309 with specific batch/serial numbers listed in the recall notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0104-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0104-2025 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.
