The Recall Desk
HighFDA (Devices)·Z-0106-2025·Announced 2024-10-23

Boston Scientific AVVIGO+ System Grid Overlay Display Software Error

Boston Scientific AVVIGO+ Multi-Modality Guidance System displays incorrect grid overlay when connected to OptiCross 18 catheters in Live or Record mode due to a software anomaly. The wrong overlay could affect reference depth settings used in vascular imaging procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with software display error affecting clinical imaging interpretation. No injuries or adverse events reported, but the incorrect overlay could lead to misinterpretation of vascular imaging data during clinical procedures.

Plain-English summary

Boston Scientific has issued a recall of the AVVIGO+ Multi-Modality Guidance System due to a software display error. The system provides physicians with imaging and physiological information during cardiovascular procedures, including intravascular ultrasound (IVUS) for evaluating blood vessels. When the OptiCross 18 Peripheral Imaging Catheter is connected in Live or Record mode, the grid mark overlay displays incorrectly.

A software anomaly causes a 9-grid mark overlay to appear instead of the correct 15-grid mark overlay. The correct overlay allows reference depth settings of 14.9mm for peripheral catheters. The error is limited to Live and Record modes; Review mode displays correctly. The incorrect grid overlay could lead to misinterpretation of imaging data during clinical decision-making.

The affected device has Material Number H7492493320D0 with batch/serial number 103874922, distributed nationally in the US and Puerto Rico. Physicians should ensure they verify imaging in Review mode when making critical clinical decisions, or contact Boston Scientific for guidance on system updates or corrective measures. No injuries or adverse events have been reported.

The recalled product

Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL 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 whic
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cardiovascular Imaging System
Hazard
  • display-error
  • grid-overlay
  • software-anomaly

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Material Number H7492493320D0
  • GTIN/UDI/DI 00191506033330
  • Batch/Serial Numbers: 103874922

Distribution

Distributed nationwide across the United States.

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