Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE 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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Material Number H7492493121I0, GTIN/UDI/DI 00191506033200, Batch/Serial Numbers: 102845321, 102845322, 102846834, 102846836, 102846938, 103226161, 103226162, 103226326, 103226455, 103234567, 103246416, 103246417, 103246469, 103452120, 103452131, 103452163, 103846738, 103846781, 103846785, 104508156, 104508175, 104508182, 104508183, 104520952, 104520973, 104520994, 104521036, 104534581, 104534587, 104534592, 104534595
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Boston Scientific Corporation
- Reason for Recall:
- 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 I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE 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.
Product Codes/Lot Numbers:
Material Number H7492493121I0, GTIN/UDI/DI 00191506033200, Batch/Serial Numbers: 102845321, 102845322, 102846834, 102846836, 102846938, 103226161, 103226162, 103226326, 103226455, 103234567, 103246416, 103246417, 103246469, 103452120, 103452131, 103452163, 103846738, 103846781, 103846785, 104508156, 104508175, 104508182, 104508183, 104520952, 104520973, 104520994, 104521036, 104534581, 104534587, 104534592, 104534595
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0113-2025
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