Boston Scientific AVVIGO+ Multi-Modality Guidance recall: Software Issue
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the system utilizes an interactive display to provide physicians…
Why was Boston Scientific AVVIGO+ Multi-Modality Guidance recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the system utilizes an interactive display to provide physicians…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 197 units
- Distribution
- US Nationwide distribution in Puerto Rico.
- Recall date
- October 23, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)