Boston Scientific recalls AVVIGO+ Multi-Modality Guidance System with incorrect 9-grid overlay when using OptiCross 18 catheter in Live/Record mode. The 15-grid overlay is needed for proper depth settings. No remedy specified in recall notice.
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 catheter in Live or Record mode. This could lead to incorrect depth settings for peripheral catheters, potentially affecting medical procedures. The recall does not include a remedy.
The software anomaly causes the system to show a 9-grid overlay instead of the required 15-grid overlay when connected to an OptiCross 18 catheter in Live or Record mode. This incorrect display may lead to improper depth settings for peripheral catheters, but the system works correctly in Review mode.
Physicians using the AVVIGO+ system with OptiCross 18 catheters during procedures. The risk is low as the issue only affects Live or Record mode and the system functions correctly in Review mode.
The system uses Material Number H7492493150I0, GTIN/UDI/DI 00191506033224, and has batch/serial numbers including 102888346, 102888349, 103233723, 103233724, 104384572, 104399815, 104420529, 104618017, 104618220.
Verify if the system is in Review mode, where the correct 15-grid overlay is displayed.
The recall indicates a software issue that may cause incorrect depth settings, but the system functions correctly in Review mode. No serious injury risk is described.
The recall does not specify a remedy, so no action is required beyond checking the system mode.
Look for Material Number H7492493150I0, GTIN/UDI/DI 00191506033224, 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-0095-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0095-2025 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.
