The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0114-2025·Announced 2024-10-23

Boston Scientific AVVIGO+ Cardiac Imaging System Grid Display Error

A software anomaly in Boston Scientific's AVVIGO+ system causes an incorrect 9-grid overlay to display instead of the correct 15-grid overlay when connected to OptiCross 18 catheters, potentially affecting clinical interpretation of vascular imaging.

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: This Class II medical device recall involves a software anomaly in an imaging system used for vascular assessment. While no injuries or illnesses have been reported, the incorrect grid overlay display could potentially lead to misinterpretation of vascular anatomy and affect clinical decision-making.

Plain-English summary

Boston Scientific is recalling the AVVIGO+ Multi-Modality Guidance System due to a software anomaly that affects the display of grid mark overlays. When the system is connected to an OptiCross 18 Peripheral Imaging Catheter in Live or Record mode, a 9-grid mark overlay is displayed instead of the correct 15-grid mark overlay. The correct 15-grid overlay allows for a reference depth setting of 14.9mm, which is appropriate for peripheral catheters.

The software anomaly is limited to Live and Record modes. When the system is used in Review mode, the correct 15-grid mark overlay displays properly and the vessel image is correctly scaled. The AVVIGO+ system is used to provide physicians with physiologic, intravascular, and intracardiac anatomical information during vascular imaging procedures.

One unit with serial number 104159021 was distributed in the United States and Puerto Rico. This recall affects healthcare facilities and physicians using the AVVIGO+ system in conjunction with OptiCross 18 Peripheral Imaging Catheters.

The recalled product

Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE EU ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various…
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cardiac/Vascular Imaging System
Hazard
Affected units
1

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 H7492493321C0
  • GTIN/UDI/DI 00191506033385
  • Batch/Serial Numbers: 104159021

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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