Boston Scientific recalls AVVIGO+ Multi-Modality Guidance System with incorrect 9-grid overlay in Live mode when using 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 catheters, potentially affecting medical procedures.
The system incorrectly shows 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 for peripheral catheters, but the issue is limited to specific imaging modes and does not cause immediate harm.
Physicians using the AVVIGO+ system with OptiCross 18 catheters during Live or Record mode. The risk is low as the issue only affects specific imaging settings and does not cause immediate harm.
The product includes Material Number H7492493120D0, GTIN/UDI/DI 00191506033149, and Batch/Serial Numbers 102899658, 103225132, 103246673, 103647916, 104043675, 104072168, 104258818, or 104512059. The system is used for intravascular ultrasound imaging by physicians.
Ensure the AVVIGO+ system is not in Live or Record mode when using an OptiCross 18 catheter.
Confirm the system displays a 15-grid overlay for OptiCross 18 catheters in Review mode, which is the correct setting.
No, the software anomaly only affects grid display in Live or Record mode and does not cause immediate harm. The issue is limited to specific imaging settings.
Check if your system has the listed Material Number or Batch/Serial Numbers. If you use it in Live or Record mode with an OptiCross 18 catheter, ensure you switch to Review mode for correct grid display.
The incorrect grid display could lead to inaccurate depth settings for peripheral catheters, but the risk is low as the issue is limited to specific imaging modes and does not cause immediate harm.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0107-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0107-2025 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.
