Boston Scientific recalls AVVIGO+ Multi-Modality Guidance System with incorrect 9-grid overlay display when used with OptiCross 18 catheter in Live/Record mode. This may lead to 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 system displays a 9-grid overlay instead of the correct 15-grid overlay when connected to an OptiCross 18 catheter in Live or Record mode. This error may cause inaccurate depth settings (14.9mm) for peripheral catheters, potentially affecting medical procedures. However, the issue does not cause injury in normal use and is corrected 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 injury.
The AVVIGO+ Multi-Modality Guidance System with Material Number H7492493120I0 or Batch/Serial Numbers listed in the record. The issue occurs only when used with OptiCross 18 Peripheral Imaging Catheter in Live or Record mode.
Ensure you are in Review mode to see the correct 15-grid overlay display for OptiCross 18 catheters.
No, the recall does not mention any injuries. The issue only affects display accuracy in specific modes.
Check if your system has Material Number H7492493120I0 or the listed Batch/Serial Numbers. The problem occurs only when connected to OptiCross 18 catheter in Live or Record mode.
The recall does not provide a fix. The issue is corrected in Review mode, but no action is needed for 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-0100-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0100-2025 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.
