The Recall Desk
ModerateFDA (Devices)·Z-0116-2025·Announced 2024-10-23

Boston Scientific Recalls AVVIGO+ Guidance Systems Due to Software Display Error

Boston Scientific is recalling 40 AVVIGO+ Multi-Modality Guidance Systems because a software anomaly causes an incorrect grid overlay to display during Live or Record mode when used with specific catheters.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences. The issue is a software display error that does not involve a structural defect or reported injuries, fitting the Moderate severity criteria for low-risk technical anomalies.

Plain-English summary

Boston Scientific Corporation is recalling 40 units of the AVVIGO+ Multi-Modality Guidance System (AVVIGO II TO AVVIGO MOB UPGRADE US). The affected devices are distributed nationwide in the United States and in Puerto Rico. The system is used by physicians to provide physiologic, intravascular, and intracardiac anatomical information, including intravascular ultrasound (IVUS) examinations.

The recall is due to a software anomaly identified by Boston Scientific. When an OptiCross 18 Peripheral Imaging Catheter is connected to the system in Live or Record mode, the device incorrectly displays a 9-grid mark overlay instead of the correct 15-grid mark overlay. This error affects the reference depth setting for peripheral catheters. The anomaly is limited to Live and Record modes; in Review mode, the correct 15-grid mark overlay is displayed, and the vessel image is correctly scaled.

Healthcare providers and facilities that have received these specific units should stop using the affected systems for Live or Record mode imaging with the OptiCross 18 Peripheral Imaging Catheter. Boston Scientific has provided specific serial numbers and material numbers to identify the affected units. Users should contact Boston Scientific for further instructions on remediation or replacement.

The recalled product

Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB 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 whi
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Imaging System
Hazard
Affected units
40

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 H7492493121C0
  • GTIN/UDI/DI 00191506033194
  • Batch/Serial Numbers: 102946988
  • 102946990
  • 102949556
  • 103199497
  • 103199500
  • 103199502
  • 103207815
  • 103207817
  • 103207860
  • 103439257
  • 103439962
  • 104233565
  • 104233569
  • 104233592
  • 104260813
  • 104278173
  • 104284141
  • 104322013

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 error

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