--- title: "Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... — FDA record Z-0100-2025 | Is It on Recall" description: "Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Im" url: https://isitonrecall.com/recall/fda-device-z-0100-2025-boston-scientific-avvigo-multi-modality-guidance-system-avvigo-int-system-us-the-system-utilizes-an/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the system utilizes an interactive ... — FDA record Z-0100-2025 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Sep 5, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes intravascular ultrasound (IVUS). When used with a peripheral vascular imaging catheter, the system utilizes the IVUS modality for ultrasound examination of intravascular pathology. - **Reason**: 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. - **Classification**: Class II - **Recalling firm**: Boston Scientific Corporation - **Quantity**: 197 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0100-2025 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0100-2025%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Material Number H7492493120I0, GTIN/UDI/DI 00191506033163, Batch/Serial Numbers: 102672283, 102672284, 102672368, 102672369, 102672371, 102672447, 102672449, 102672450, 102697688, 102763844, 102770998, 102770999, 102780704, 102783352, 102783523, 102783889, 102789480, 102789481, 102789482, 102789483, 102790372, 102802930, 102818477, 102821169, 102825973, 102825975, 102826221, 102826222, 102826341, 102826343, 102826344, 102826345, 102834354, 103058093, 103058094, 103058095, 103058096, 103060351, 103069656, 103069657, 103070940, 103070941, 103114697, 103114702, 103114704, 103115068, 103146535, 103146634, 103187195, 103187197, 103279847, 103440756, 103452968, 103467274, 103467275, 103468394, 103472692, 103472693, 103472735, 103484496, 103492544, 103492910, 103492911, 103493823, 103493824, 103493952, 103494351, 103494352, 103878977, 103878980, 103882309, 103882319, 103882361, 103882363, 103882366, 103882370, 103882375, 103882458, 103891927, 103891934, 103892273, 103892274, 103892276, 103898590, 103898591, 103898594, 103898595, 103899504, 103994061, 103994062, 103997126, 103997129, 103997158, 103997551, 103997557, 103997559, 104249765, 104249767, 104249769, 104259397, 104259411, 104284339, 104284340, 104284347, 104294234, 104294397, 104294430, 104294439, 104294441, 104294443, 104438165, 104440246, 104440277, 104440278, 104445800, 104445845, 104447404, 104447518, 104448273, 104460784, 104463982, 104463983, 104463984, 104464011, 104464019, 104467987, 104467988, 104469855, 104469856, 104469860, 104469941, 104473084, 104473088, 104473097, 104474525, 104474528, 104479345, 104479347, 104479348, 104479349, 104495692, 104612940, 104612942, 104614587, 104614591, 104614593, 104617960, 104654692, 104654694, 104654696, 104660577, 104660581, 104663640, 104663641, 104663642, 104663644, 104663758, 104663759, 104663765, 104674718, 104675999, 104676011, 104676064, 104680611, 104680612, 104680613, 104684408, 104684415, 104689231, 104696580, 104696587, 104696588, 104698775, 104717639, 104717711, 104719525, 104719526, 104720443, 104720458, 104720460, 104733854, 104733856, 104733879, 104733882, 104733883, 104738767, 104738860, 104738862, 104739542, 104739997, 104740004, 104743322, 104743325, 104743378, 104744548, 104744572, 104758088 | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US Nationwide distribution in Puerto Rico. States below are derived from the distribution text, including nationwide wording. 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These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0100-2025%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Boston Scientific Corporation records](https://isitonrecall.com/brand/boston-scientific-corporation/)