—#210005

Product

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.

FDA product code: DQK — Computer, Diagnostic, Programmable
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K230884
Affected lot / code info: Material Number H7492493320CZ0, GTIN/UDI/DI 00191506033323, Batch/Serial Numbers: 104877663, 104883563, 104890983, 104895226, 105036836

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: US Nationwide distribution in Puerto Rico.

Timeline

Recall initiated: 2024-09-05
Posted by FDA: 2024-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210005. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.