Agency classClass IIOur severity:High FDA (Devices)·Z-0097-2025·Announced 2024-10-23

AVVIGO+ Multi-Modality Guidance System software defect causes incorrect grid display

Boston Scientific recalled the AVVIGO+ Multi-Modality Guidance System because a software defect causes incorrect grid display in Live and Record modes, potentially affecting vessel imaging guidance for physicians using OptiCross 18 catheters.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 no reported hospitalizations, injuries, or illnesses. The hazard is a software defect causing incorrect imaging display in a safety-critical cardiovascular guidance system, but no actual harm has been reported, placing it at most a 3 per the rubric.

Plain-English summary

Boston Scientific has recalled the AVVIGO+ Multi-Modality Guidance System due to a software defect affecting its interactive display. When an OptiCross 18 Peripheral Imaging Catheter is connected to the AVVIGO+ system in Live or Record mode, the grid mark overlay on the cross-sectional view displays incorrectly.

The software defect causes a 9-grid mark overlay to display instead of the correct 15-grid mark overlay during Live mode. The correct 15-grid mark overlay provides a reference depth setting of 14.9 mm for peripheral catheters. The incorrect display also results in improper vessel image scaling.

In Review mode, the system displays the correct 15-grid mark overlay with proper vessel image scaling. The defect is limited to Live and Record modes.

Two units were distributed nationwide, including in Puerto Rico.

The recalled product

Product: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities…
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Intravascular Imaging System
Hazard: software-defect
display-error
Affected units: 2

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 (4)

Material Number H7492493120IZ0
GTIN/UDI/DI 00191506033187
Batch/Serial Numbers: 103060348
103060349

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 22 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 22 products in this recall →

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Same hazard · software defect