Recall Z-0097-2025 ยท DQK Computer, Diagnostic, Programmable
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST 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
| Date | Oct 16, 2024 (initiated Sep 5, 2024) |
| Status | Open, Classified |
| 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 refere |
| Root cause | Under Investigation by firm |
| Action | Boston Scientific issued a Product Advisory notice to its consignees beginning on 09/05/2024 via mail, email or hand delivery. The notice explained the problem with the device, clinical impact, and provided recommendations for safe usage until a software update is available to address the anomaly. Boston Scientific is developing a software update to address this anomaly. The consignees were directed to immediately post this product advisory in a visible location near the AVVIGO+ Multi-Modality Guidance System to ensure this information is easily accessible to users. Also, share this product |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230884 | AVVIGO'+ Multi-Modality Guidance System Boston Scientific Corporation, Sep 26, 2023 |