Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST JAPAN; 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 H7492493220CZ0, GTIN/UDI/DI 00191506040482, Batch/Serial Numbers: 102991580, 102991581, 103044290, 103044291, 103044574, 103044577, 103045131, 103046258, 103049558, 103082231, 103082236, 103083046, 103138559, 103161660, 103161661, 103162801, 103163114, 103163116, 103163310, 103163312, 103426739, 103426983, 103460621, 103460622, 103542656, 103554562, 103565449, 103578369, 103648168, 103648304, 103649576, 103652219, 103652220, 103652529, 103652531, 103679467, 103679469, 103679552, 103679554, 103680003, 103683853, 103683854, 103729193, 103729194, 103732842, 103732843, 103754686, 103755483, 103755485, 103770200, 103770201, 103770291, 103770310, 103770451, 103770452, 103770453, 103770454, 103782346, 103782396, 103782397, 103782503, 103782581, 103782582, 103784279, 103798726, 103799816, 103801787, 104075451, 104075673, 104079162, 104082341, 104086595, 104086597, 104086599, 104227518, 104227521, 104228853, 104228854, 104237508, 104237509, 104237585, 104237588, 104238628, 104238629, 104238852, 104245995, 104246036, 104259376, 104423789, 104423793, 104438145, 104438152, 104972341, 104972343, 104972344, 104972345, 104975065, 104975066, 104976109, 104976110, 104977543, 104995049, 104999839, 105008687, 105008716, 105008717, 105014147, 105014722, 105014724, 105022928, 105022930, 105028203, 105028205, 105150552, 105152109, 105154989, 105161515, 105165834, 105165835, 105165836, 105165837, 105178871, 105178878, 105224149
- 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 + MOB SYSTEM - ZERO COST JAPAN; 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 H7492493220CZ0, GTIN/UDI/DI 00191506040482, Batch/Serial Numbers: 102991580, 102991581, 103044290, 103044291, 103044574, 103044577, 103045131, 103046258, 103049558, 103082231, 103082236, 103083046, 103138559, 103161660, 103161661, 103162801, 103163114, 103163116, 103163310, 103163312, 103426739, 103426983, 103460621, 103460622, 103542656, 103554562, 103565449, 103578369, 103648168, 103648304, 103649576, 103652219, 103652220, 103652529, 103652531, 103679467, 103679469, 103679552, 103679554, 103680003, 103683853, 103683854, 103729193, 103729194, 103732842, 103732843, 103754686, 103755483, 103755485, 103770200, 103770201, 103770291, 103770310, 103770451, 103770452, 103770453, 103770454, 103782346, 103782396, 103782397, 103782503, 103782581, 103782582, 103784279, 103798726, 103799816, 103801787, 104075451, 104075673, 104079162, 104082341, 104086595, 104086597, 104086599, 104227518, 104227521, 104228853, 104228854, 104237508, 104237509, 104237585, 104237588, 104238628, 104238629, 104238852, 104245995, 104246036, 104259376, 104423789, 104423793, 104438145, 104438152, 104972341, 104972343, 104972344, 104972345, 104975065, 104975066, 104976109, 104976110, 104977543, 104995049, 104999839, 105008687, 105008716, 105008717, 105014147, 105014722, 105014724, 105022928, 105022930, 105028203, 105028205, 105150552, 105152109, 105154989, 105161515, 105165834, 105165835, 105165836, 105165837, 105178871, 105178878, 105224149
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0102-2025
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