Boston Scientific recalls AVVIGO+ Multi-Modality Guidance System with incorrect 9-grid overlay when using OptiCross 18 catheter in Live/Record mode. This may cause inaccurate depth settings for peripheral catheters.
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 connected to an OptiCross 18 Peripheral Imaging Catheter in Live or Record mode. This could lead to inaccurate depth settings for peripheral catheters, potentially affecting medical procedures.
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, potentially affecting medical procedures. However, the issue does not affect Review mode where the correct display is shown.
Physicians using the AVVIGO+ system with OptiCross 18 catheters in Live or Record mode. The risk is low as the issue only affects specific software modes and does not cause immediate harm.
The system uses a Material Number H7492493121C0, GTIN/UDI/DI 00191506033194, and has specific batch/serial numbers listed in the recall notice. It is designed for medical use with intravascular ultrasound imaging.
Verify if the system is in Live or Record mode when connected to an OptiCross 18 catheter.
If in Review mode, the correct 15-grid overlay is displayed and the vessel image is properly scaled.
Boston Scientific found a software issue 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.
Incorrect depth settings (14.9mm) could affect peripheral catheter procedures, but the issue only occurs in Live or Record mode and not in Review mode.
Check for Material Number H7492493121C0, GTIN/UDI/DI 00191506033194, and 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-0116-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0116-2025 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.
