Reported Oct 23, 2024 · Ongoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- 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.
- Lot codes and dates
Material Number H7492493320C0GTIN/UDI/DI 00191506033309
- Batch/Serial Numbers
103189853103416434103416437103416600103416629103416630103416690103469208103552000103552353103645606103645607103667250103710560103711075103799547104033389104035234104042507104112099104112181104113877104119696104124626104124634104125281104125291104185271104185745104196585104210922104212968104338136104340593104523528104535237104535289104548777104573317104586006104586008104586060104596504104597121104597142104877669104884458104889669104890938104890985104902736105072735105092091105092230105092231105471081105491421105542133
- Amount recalled
- 58 units
This recall covers 22 products
The agency filed one notice per product. You are reading one of them; the other 21 are below.
9 more are in the archive.
Where it was sold
- Nationwide
- PR
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.
This product could cause temporary or reversible health problems — stop using it.
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