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 Peripheral Imaging 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 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 catheters, but the system functions correctly in Review mode.
Physicians using the AVVIGO+ system with OptiCross 18 catheters for vascular imaging procedures. The risk is low as the issue only affects Live or Record mode and the system works correctly in Review mode.
This system uses an interactive display for vascular imaging. Check for Material Number H7492493320CZ0, GTIN/UDI/DI 00191506033323, or Batch/Serial Numbers 104877663, 104883563, 104890983, 104895226, 105036836.
Verify if the system is in Review mode, where the correct 15-grid overlay is displayed and vessel images are properly scaled.
Boston Scientific found a software anomaly that causes the system 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.
The risk is low as the issue only affects Live or Record mode, and the system functions correctly in Review mode with the proper 15-grid overlay.
Check for Material Number H7492493320CZ0, GTIN/UDI/DI 00191506033323, or Batch/Serial Numbers 104877663, 104883563, 104890983, 104895226, 105036836.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0101-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0101-2025 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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