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AVVIGO+ recallZ-0100-2025 · Boston Scientific Corporation · initiated Sep 5, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Under Investigation by firm

What the company is doing

Boston Scientific issued a Product Advisory notice to its consignees beginning on 09/05/2024 via mail, email or hand delivery. The notice explained the problem with the device, clinical impact, and provided recommendations for safe usage until a software update is available to address the anomaly. Boston Scientific is developing a software update to address this anomaly. The consignees were directed to immediately post this product advisory in a visible location near the AVVIGO+ Multi-Modality Guidance System to ensure this information is easily accessible to users. Also, share this product advisory with any health care professional within your organization that needs to be aware and/or with any organization where the affected devices have been transferred (if appropriate). If you are a distributor, this product advisory must be forwarded to your customers to ensure notification of this product advisory is carried out to the end-user level.

Recall details

Recall number
Z-0100-2025
Status
Open, Classified
Initiated by the company
Sep 5, 2024
Posted by the FDA
Oct 16, 2024
Recalling firm
Boston Scientific Corporation
Quantity
197 units
Product code
DQK
FDA submissions
K230884
Distribution
US Nationwide distribution in Puerto Rico.

Product description

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.

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 95331).

Sources and updates

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