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Lower risk Medical device recall · FDA · Published September 5, 2024

Boston Scientific AVVIGO+ System: Incorrect Grid Overlay in Live Mode

Boston Scientific recalls AVVIGO+ Multi-Modality Guidance System with incorrect 9-grid overlay in Live mode when used with OptiCross 18 catheter. This may cause inaccurate depth settings for peripheral vascular imaging.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0105-2025Medical deviceBoston Scientific ›
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Recalling firmBoston Scientific Corporation1 Scimed Pl · Maple Grove, MN 55311-1565
✎ GovInfoNow plain-language explainer

Boston Scientific is recalling its AVVIGO+ Multi-Modality Guidance System because a software issue causes it to display a 9-grid overlay instead of the correct 15-grid overlay when used with an OptiCross 18 catheter in Live or Record mode. This could lead to inaccurate depth settings for peripheral vascular imaging procedures. Read more at govinfonow.com/recall/54045-boston-scientific-avvigo-system-incorrect-grid-overlay-in-live-mode.

Source Summary by GovInfoNow · govinfonow.com/recall/54045-boston-scientific-avvigo-system-incorrect-grid-overlay-in-live-mode · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0105-2025

Cite this page

“Boston Scientific AVVIGO+ System: Incorrect Grid Overlay in Live Mode.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54045-boston-scientific-avvigo-system-incorrect-grid-overlay-in-live-mode. Based on FDA recall #Z-0105-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0105-2025%22&limit=1).

The FDA announced on Sept. 5, 2024, that Boston Scientific Corporation is voluntarily recalling its AVVIGO+ Multi-Modality Guidance System due to a software anomaly causing an incorrect grid mark overlay during Live or Record mode. The recall affects six units distributed nationwide in the U.S. and Puerto Rico.

How to tell if you have it

  • Brand: Boston Scientific
  • Product: AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US
  • Material Number: H7492493120DZ0
  • GTIN/UDI/DI: 00191506033156
  • Batch/Serial Numbers: 102856880, 102994713, 103058232, 103468307, 103542491, 103638657

The hazard

According to the FDA, a software anomaly causes a 9-grid mark overlay to be incorrectly displayed during Live mode when the system is connected to an OptiCross 18 Peripheral Imaging Catheter. The correct display should be a 15-grid mark overlay with a reference depth setting of 14.9mm for peripheral catheters. This error occurs in Live or Record mode, while Review mode displays the correct overlay.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Other recent recalls include Boston Scientific Imager II Angiographic Catheters Recall: Tip Fracture Risk (Aug. 24, 2026) and Boston Scientific LUX-Dx Cardiac Monitor System Recall: Delayed AF Burden Alerts (Aug. 6, 2026). A July 22, 2026 recall involved Boston Scientific StoneSmart Connect Console Power Adapters that may fail safety testing.

How to tell if you have this one

Check for the product with Material Number H7492493120DZ0, GTIN/UDI/DI 00191506033156, and Batch/Serial Numbers 102856880, 102994713, 103058232, 103468307, 103542491, or 103638657.

  • Brand
    Boston Scientific
  • Category
    Medical device
FDA recall event · 22 products

All 22 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution in Puerto Rico.
Recall numberProduct, codes & lotsQuantity
Z-0095-2025Boston 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.; Material Number H7492493150I0, GTIN/UDI/DI 00191506033224, Batch/Serial Numbers: 102888346, 102888349, 103233723, 103233724, 104384572, 104399815, 104420529, 104618017, 1046182209 units
Z-0096-2025Boston 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.; Material Number H7492493220IZ0, GTIN/UDI/DI 00191506033279, Batch/Serial Numbers: 102929196, 102929197, 103224212, 103900781, 1039008045 units
Z-0097-2025Boston 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.; Material Number H7492493120IZ0, GTIN/UDI/DI 00191506033187, Batch/Serial Numbers: 103060348, 1030603492 units
Z-0098-2025Boston 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.; Material Number H7492493320I0, GTIN/UDI/DI 00191506033354, Batch/Serial Numbers: 103810801, 103811529, 103824292, 103826195, 103882483, 103961608, 103961637, 104098361, 104098367, 104108403, 104927614, 104927862, 104930144, 104931985, 10534241915 units
Z-0099-2025Boston 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.; Material Number H7492493220I0, GTIN/UDI/DI 00191506033255, Batch/Serial Numbers: 103900407, 1046506922 units
Z-0100-2025Boston 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.; 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, 104758088197 units
Z-0101-2025Boston 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.; Material Number H7492493320CZ0, GTIN/UDI/DI 00191506033323, Batch/Serial Numbers: 104877663, 104883563, 104890983, 104895226, 1050368365 units
Z-0102-2025Boston 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.; 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, 105224149124 units
Z-0103-2025Boston 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.; Material Number H7492493120CZ0, GTIN/UDI/DI 00191506040475, Batch/Serial Numbers: 102977628, 104021484, 104022028, 104146755, 104667579, 104667581, 104755556, 104797259, 104800029, 104801609, 104833779, 105121661, 105136549, 10513989814 units
Z-0104-2025Boston 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.; 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, 10554213358 units
Z-0105-2025Boston 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.; Material Number H7492493120DZ0, GTIN/UDI/DI 00191506033156, Batch/Serial Numbers: 102856880, 102994713, 103058232, 103468307, 103542491, 1036386576 units
Z-0106-2025Boston 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.; Material Number H7492493320D0, GTIN/UDI/DI 00191506033330, Batch/Serial Numbers: 1038749221 unit
Z-0107-2025Boston 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.; Material Number H7492493120D0, GTIN/UDI/DI 00191506033149, Batch/Serial Numbers: 102899658, 103225132, 103246673, 103647916, 104043675, 104072168, 104258818, 1045120598 units
Z-0108-2025Boston 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.; Material Number H7492493220C0, GTIN/UDI/DI 00191506033231, Batch/Serial Numbers: 103045130, 103427062, 103427064, 103460623, 103545307, 103545308, 103679278, 103679281, 1036800049 units
Z-0109-2025Boston 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.; 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, 105146787161 units
Z-0110-2025Boston 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.; Material Number H7492493221IZ0, GTIN/UDI/DI 00191506047443, Batch/Serial Numbers: 102971349, 102971350, 103223891, 103441162, 1034727605 units
Z-0111-2025Boston 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.; 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, 10492693092 units
Z-0112-2025Boston 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.; Material Number H7492493221I0, GTIN/UDI/DI 00191506033293, Batch/Serial Numbers: 1034948071 unit
Z-0113-2025Boston 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.; 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, 10453459531 units
Z-0114-2025Boston 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.; Material Number H7492493321C0, GTIN/UDI/DI 00191506033385, Batch/Serial Numbers: 1041590211 unit
Z-0115-2025Boston 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.; Material Number H7492493221C0, GTIN/UDI/DI 00191506033286, Batch/Serial Numbers: 103034438, 103198701, 104179696, 1049109624 units
Z-0116-2025Boston 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.; 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, 10460116240 units
Based on the official FDA remedy

What to do — step by step

  1. Check System Mode

    Verify if the system is in Live or Record mode when using the OptiCross 18 catheter.

  2. Use Review Mode

    If the issue occurs, switch to Review mode for accurate 15-grid overlay display.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “US Nationwide distribution in Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 48 days after the firm started it.

1. Firm started the recall: Sep 5, 202412. FDA classified it Class II: Oct 16, 202423. Published in FDA’s Enforcement Report: Oct 23, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0105-2025 (September 5, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0105-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA