Boston Scientific recalls AVVIGO+ Multi-Modality Guidance System for incorrect grid overlay when using OptiCross 18 catheter in Live or Record mode. The 9-grid display may cause depth measurement errors.
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 for a software issue that causes an incorrect 9-grid overlay display when used with an OptiCross 18 catheter in Live or Record mode. This could lead to inaccurate depth measurements for peripheral catheters, potentially affecting medical procedures.
The software anomaly displays a 9-grid overlay instead of the correct 15-grid overlay when connected to OptiCross 18 catheters in Live or Record mode. This incorrect display may cause depth measurement errors, potentially affecting the accuracy of peripheral vascular imaging procedures.
Medical professionals using the AVVIGO+ system with OptiCross 18 catheters in Live or Record mode. The risk is highest for those performing procedures requiring precise depth measurements.
Check for the product name 'AVVIGO+ Multi-Modality Guidance System' with Material Number H7492493221I0, GTIN/UDI/DI 00191506033293, and Batch/Serial Numbers starting with 103494807.
Ensure the system is not in Live or Record mode when using the OptiCross 18 catheter.
The recall indicates a software anomaly that may cause incorrect depth measurements, but it does not mention risk of injury or serious harm. The hazard is limited to potential measurement errors during procedures.
The recall does not specify a remedy, so no action is required beyond checking system mode to avoid Live or Record mode when using OptiCross 18 catheters.
The issue is specific to OptiCross 18 Peripheral Imaging Catheters when used with AVVIGO+ in Live or Record mode. Other catheters are unaffected.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0112-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0112-2025 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.
