Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST JAPAN; the system utilizes an
Summary
The FDA issued a Class II for Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - by Boston Scientific Corporation. Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Per.
Details
Source
Device Recall
External ID
Z-0102-2025
Action Date
2024-10-23
Status
Ongoing
Category
device
Product 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.
Lot/Code Info: 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
Quantity Affected: 124 units
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.
Distribution
US Nationwide distribution in Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-05
Company
Maple Grove, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Corporation have FDA actions?
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0102-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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