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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95331

22 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 05, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Boston Scientific Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

22 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 22

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; 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.

Z-0095-2025
Recall number
Z-0095-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
9 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Material Number H7492493150I0, GTIN/UDI/DI 00191506033224, Batch/Serial Numbers: 102888346, 102888349, 103233723, 103233724, 104384572, 104399815, 104420529, 104618017, 104618220

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 2 of 22

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT 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.

Z-0096-2025
Recall number
Z-0096-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
5 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Material Number H7492493220IZ0, GTIN/UDI/DI 00191506033279, Batch/Serial Numbers: 102929196, 102929197, 103224212, 103900781, 103900804

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 3 of 22

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 the IVUS modality for ultrasound examination of intravascular pathology.

Z-0097-2025
Recall number
Z-0097-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
2 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Material Number H7492493120IZ0, GTIN/UDI/DI 00191506033187, Batch/Serial Numbers: 103060348, 103060349

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 4 of 22

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM EU + ROW; 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.

Z-0098-2025
Recall number
Z-0098-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
15 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Material Number H7492493320I0, GTIN/UDI/DI 00191506033354, Batch/Serial Numbers: 103810801, 103811529, 103824292, 103826195, 103882483, 103961608, 103961637, 104098361, 104098367, 104108403, 104927614, 104927862, 104930144, 104931985, 105342419

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 5 of 22

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM 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.

Z-0099-2025
Recall number
Z-0099-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
2 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Material Number H7492493220I0, GTIN/UDI/DI 00191506033255, Batch/Serial Numbers: 103900407, 104650692

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 6 of 22

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.

Z-0100-2025
Recall number
Z-0100-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
197 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 7 of 22

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; 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.

Z-0101-2025
Recall number
Z-0101-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
5 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Material Number H7492493320CZ0, GTIN/UDI/DI 00191506033323, Batch/Serial Numbers: 104877663, 104883563, 104890983, 104895226, 105036836

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 8 of 22

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.

Z-0102-2025
Recall number
Z-0102-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
124 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 9 of 22

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB 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 the IVUS modality for ultrasound examination of intravascular pathology.

Z-0103-2025
Recall number
Z-0103-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
14 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Material Number H7492493120CZ0, GTIN/UDI/DI 00191506040475, Batch/Serial Numbers: 102977628, 104021484, 104022028, 104146755, 104667579, 104667581, 104755556, 104797259, 104800029, 104801609, 104833779, 105121661, 105136549, 105139898

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 10 of 22

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; 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.

Z-0104-2025
Recall number
Z-0104-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
58 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Material Number H7492493320C0, GTIN/UDI/DI 00191506033309, Batch/Serial Numbers: 103189853, 103416434, 103416437, 103416600, 103416629, 103416630, 103416690, 103469208, 103552000, 103552353, 103645606, 103645607, 103667250, 103710560, 103711075, 103799547, 104033389, 104035234, 104042507, 104112099, 104112181, 104113877, 104119696, 104124626, 104124634, 104125281, 104125291, 104185271, 104185745, 104196585, 104210922, 104212968, 104338136, 104340593, 104523528, 104535237, 104535289, 104548777, 104573317, 104586006, 104586008, 104586060, 104596504, 104597121, 104597142, 104877669, 104884458, 104889669, 104890938, 104890985, 104902736, 105072735, 105092091, 105092230, 105092231, 105471081, 105491421, 105542133

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 11 of 22

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - 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 the IVUS modality for ultrasound examination of intravascular pathology.

Z-0105-2025
Recall number
Z-0105-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
6 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Material Number H7492493120DZ0, GTIN/UDI/DI 00191506033156, Batch/Serial Numbers: 102856880, 102994713, 103058232, 103468307, 103542491, 103638657

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 12 of 22

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL EU + ROW; 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.

Z-0106-2025
Recall number
Z-0106-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
1 unit

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Material Number H7492493320D0, GTIN/UDI/DI 00191506033330, Batch/Serial Numbers: 103874922

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 13 of 22

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL 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.

Z-0107-2025
Recall number
Z-0107-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
8 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Material Number H7492493120D0, GTIN/UDI/DI 00191506033149, Batch/Serial Numbers: 102899658, 103225132, 103246673, 103647916, 104043675, 104072168, 104258818, 104512059

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 14 of 22

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM 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.

Z-0108-2025
Recall number
Z-0108-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
9 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Material Number H7492493220C0, GTIN/UDI/DI 00191506033231, Batch/Serial Numbers: 103045130, 103427062, 103427064, 103460623, 103545307, 103545308, 103679278, 103679281, 103680004

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 15 of 22

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB 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.

Z-0109-2025
Recall number
Z-0109-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
161 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Material Number H7492493120C0, GTIN/UDI/DI 00191506033125, Batch/Serial Numbers: 102724831, 102736254, 102739481, 102739533, 102739635, 102739691, 102747478, 102748619, 102752007, 102752009, 102752010, 102752395, 102763175, 102857045, 102857046, 102857638, 102858984, 102859728, 102860593, 102872633, 102872634, 102872636, 102874718, 102900356, 102910971, 102911356, 102918713, 102927927, 102928248, 102928827, 102932993, 102932994, 102933234, 102934052, 102934075, 102948699, 102948700, 102958074, 102970652, 102971466, 102978508, 102980261, 102980262, 102988595, 102990008, 103083371, 103083462, 103099539, 103099543, 103114508, 103115704, 103119356, 103127420, 103127696, 103131270, 103166819, 103166957, 103167771, 103187219, 103208658, 103209501, 103210318, 103210974, 103246763, 103442205, 103442227, 103452461, 103453092, 103484498, 104021165, 104026019, 104026081, 104026383, 104026586, 104031272, 104031297, 104126629, 104146350, 104146352, 104146822, 104146826, 104146831, 104146838, 104146866, 104146871, 104148636, 104148713, 104208177, 104208211, 104208216, 104208868, 104208922, 104219001, 104219647, 104219649, 104221489, 104227135, 104354864, 104371873, 104374276, 104380868, 104384808, 104384911, 104387708, 104397652, 104400093, 104403872, 104404203, 104419880, 104419893, 104419919, 104647863, 104647894, 104650513, 104666682, 104666685, 104673058, 104751209, 104755550, 104771280, 104771287, 104780803, 104781129, 104781136, 104786917, 104788864, 104796967, 104797260, 104798419, 104803143, 104807527, 104808883, 104811360, 104813989, 104814198, 104818951, 104818988, 104819688, 104819702, 104821763, 104825997, 104831952, 104836658, 104836680, 104837178, 104870500, 104871241, 104871255, 104872271, 105107690, 105107695, 105121659, 105128877, 105133223, 105133225, 105136550, 105136911, 105139406, 105139411, 105146694, 105146787

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 16 of 22

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; 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.

Z-0110-2025
Recall number
Z-0110-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
5 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Material Number H7492493221IZ0, GTIN/UDI/DI 00191506047443, Batch/Serial Numbers: 102971349, 102971350, 103223891, 103441162, 103472760

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 17 of 22

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; 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.

Z-0111-2025
Recall number
Z-0111-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
92 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Material Number H7492493221CZ0, GTIN/UDI/DI 00191506047436, Batch/Serial Numbers: 102991870, 102991872, 102991873, 102991874, 103004336, 103004337, 103004339, 103004340, 103006963, 103006965, 103006966, 103007173, 103007176, 103007177, 103007178, 103007380, 103007481, 103007583, 103007584, 103014566, 103014567, 103014569, 103014571, 103017674, 103017675, 103017676, 103017680, 103033749, 103033751, 103034435, 103034436, 103034437, 103036108, 103036122, 103036123, 103036124, 103045960, 103208294, 103208295, 103208297, 103208298, 103416751, 103416752, 103416786, 103416788, 103426736, 103426742, 103426744, 103426745, 103427294, 103427295, 103427297, 103427334, 103427577, 103428138, 103428141, 103428142, 103428143, 103430679, 103430680, 103430681, 104069643, 104069644, 104083192, 104083195, 104083196, 104085311, 104085312, 104085313, 104085314, 104085316, 104085317, 104159043, 104179572, 104179659, 104179664, 104179687, 104179688, 104179690, 104179693, 104179695, 104179706, 104179715, 104179985, 104902848, 104902849, 104903242, 104907814, 104910955, 104910956, 104911201, 104926930

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 18 of 22

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE 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.

Z-0112-2025
Recall number
Z-0112-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
1 unit

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Material Number H7492493221I0, GTIN/UDI/DI 00191506033293, Batch/Serial Numbers: 103494807

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 19 of 22

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.

Z-0113-2025
Recall number
Z-0113-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
31 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 20 of 22

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE EU ROW; 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.

Z-0114-2025
Recall number
Z-0114-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
1 unit

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Material Number H7492493321C0, GTIN/UDI/DI 00191506033385, Batch/Serial Numbers: 104159021

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 21 of 22

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE 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.

Z-0115-2025
Recall number
Z-0115-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
4 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Material Number H7492493221C0, GTIN/UDI/DI 00191506033286, Batch/Serial Numbers: 103034438, 103198701, 104179696, 104910962

Distribution pattern

US Nationwide distribution in Puerto Rico.

device · product 22 of 22

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB 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.

Z-0116-2025
Recall number
Z-0116-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Quantity
40 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Material Number H7492493121C0, GTIN/UDI/DI 00191506033194, Batch/Serial Numbers: 102946988, 102946990, 102949556, 103199497, 103199500, 103199502, 103207815, 103207817, 103207860, 103439257, 103439962, 104233565, 104233569, 104233592, 104260813, 104278173, 104284141, 104322013, 104322062, 104322063, 104322064, 104322065, 104329117, 104329122, 104330747, 104330955, 104333933, 104340756, 104340852, 104340854, 104341075, 104350753, 104350860, 104350861, 104599296, 104599354, 104601145, 104601146, 104601151, 104601162

Distribution pattern

US Nationwide distribution in Puerto Rico.