The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0113-2025·Announced 2024-10-23

Boston Scientific AVVIGO+ Guidance System Grid Mark Display Error

Boston Scientific is recalling the AVVIGO+ Guidance System due to a software bug displaying incorrect grid marks during live imaging. The device shows 9 grid marks instead of 15, which could affect accurate vessel measurement in cardiac interventions.

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: The device qualifies as a risk-of-harm product because incorrect grid mark display could affect vessel measurement accuracy in interventional cardiology procedures. No injuries, deaths, or illnesses have been reported. The FDA classified this as a Class II recall, indicating moderate public health significance.

Plain-English summary

The Boston Scientific AVVIGO+ Multi-Modality Guidance System is being recalled due to a software display error. The system provides physicians with physiologic and anatomical information for vessel imaging and interventional procedures. Thirty-one units have been distributed nationwide.

When connected to an OptiCross 18 Peripheral Imaging Catheter in Live or Record mode, the AVVIGO+ system displays an incorrect grid mark overlay. The system shows a 9-grid overlay instead of the correct 15-grid overlay. The correct 15-grid overlay allows for a proper reference depth setting of 14.9mm for peripheral catheters. In Review mode, the system displays correctly with the proper 15-grid overlay.

Boston Scientific's investigation determined the problem is a software anomaly that occurs only in Live and Record modes when the peripheral imaging catheter is connected. The incorrect grid overlay does not affect the system's performance in Review mode, where the vessel image is correctly scaled.

The recalled product

Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE 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 — Vascular Imaging System
Hazard
Affected units
31

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 (20)

  • Material Number H7492493121I0
  • GTIN/UDI/DI 00191506033200
  • Batch/Serial Numbers: 102845321
  • 102845322
  • 102846834
  • 102846836
  • 102846938
  • 103226161
  • 103226162
  • 103226326
  • 103226455
  • 103234567
  • 103246416
  • 103246417
  • 103246469
  • 103452120
  • 103452131
  • 103452163
  • 103846738
  • 103846781

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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