Boston Scientific Corporation: Medical Device Recall in 2024 - (Recall #: Z-0115-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN; 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.

Product Classification:

Class II

Date Initiated: September 5, 2024

Date Posted: October 23, 2024

Recall Number: Z-0115-2025

Event ID: 95331

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.

Status: Ongoing

Product Quantity: 4 units

Code Information:

Material Number H7492493221C0, GTIN/UDI/DI 00191506033286, Batch/Serial Numbers: 103034438, 103198701, 104179696, 104910962

Distribution Pattern:

US Nationwide distribution in Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated