Boston Scientific recalls AVVIGO+ Multi-Modality Guidance System (AVVIGO II to AVVIGO INT upgrade) due to incorrect 9-grid overlay display when using OptiCross 18 catheter in Live/Record mode, potentially affecting depth settings.
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 (AVVIGO II to AVVIGO INT upgrade) because a software issue causes it 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 for peripheral catheters, though the system works correctly in Review mode.
The software anomaly causes the system to show 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 catheters, but the system functions properly in Review mode.
Physicians using the AVVIGO+ system with OptiCross 18 catheters in Live or Record mode. The risk is low as the issue only affects specific display modes and does not cause immediate harm.
Check for the product name 'AVVIGO+ Multi-Modality Guidance System' with model numbers 102845321 through 104534595. The system was sold in the US for medical use with OptiCross 18 catheters.
Ensure you are not in Live or Record mode when using the system with an OptiCross 18 catheter.
Switch to Review mode for correct 15-grid overlay display and proper vessel scaling.
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 displays incorrectly.
The official recall does not mention a fix; the issue is resolved by using Review mode instead of 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-0113-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0113-2025 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.
