Class 2 Device Recall Boston Scientific AVVIGO

• Date Initiated by Firm: September 05, 2024
• Date Posted: October 16, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0098-2025
• Recall Event ID: 95331
• 510(K)Number: K230884
• Product Classification: Computer, diagnostic, programmable - Product Code DQK
• Product: Boston 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.
• Code Information: Material Number H7492493320I0, GTIN/UDI/DI 00191506033354, Batch/Serial Numbers: 103810801, 103811529, 103824292, 103826195, 103882483, 103961608, 103961637, 104098361, 104098367, 104108403, 104927614, 104927862, 104930144, 104931985, 105342419
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 1 Scimed Pl; Maple Grove MN 55311-1565
• For Additional Information Contact: Rebecca KinKead Rubio; 763-494-1133
• Manufacturer Reason for Recall: 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 Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 15 units
• Distribution: US Nationwide distribution in Puerto Rico.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DQK