Boston Scientific recalls AVVIGO+ Multi-Modality Guidance System with incorrect 9-grid overlay when used with OptiCross 18 catheter in Live/Record mode. The 15-grid overlay is correct for reference 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 due to a software error that shows a 9-grid overlay instead of the correct 15-grid overlay when used with an OptiCross 18 Peripheral Imaging Catheter in Live or Record mode. This error could lead to incorrect depth settings for peripheral catheters, potentially affecting medical 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 incorrect overlay may lead to inaccurate depth settings for peripheral catheters, but the error does not affect the system's operation in Review mode.
Physicians using the AVVIGO+ system with OptiCross 18 catheters for intravascular ultrasound procedures. The risk is low as the error only affects Live or Record mode and the system functions correctly in Review mode.
The system has a Material Number H7492493120C0, GTIN/UDI/DI 00191506033125, and specific batch/serial numbers listed in the recall notice. It is used with OptiCross 18 Peripheral Imaging Catheters for intravascular ultrasound procedures.
Verify if the system is in Review mode, as the correct 15-grid overlay is displayed there.
Boston Scientific found a software anomaly that 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.
The error only affects Live and Record modes, and the system functions correctly in Review mode. The risk is low as it does not cause immediate injury or affect the system's overall safety.
Check if your system is in Review mode; if so, it is safe. If in Live or Record mode, ensure you are using the system correctly with the OptiCross 18 catheter.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0109-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0109-2025 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.
