The Recall Desk
ModerateFDA (Devices)·Z-0098-2025·Announced 2024-10-23

Boston Scientific Recalls AVVIGO+ Guidance System Due to Software Anomaly

Boston Scientific is recalling 15 units of the AVVIGO+ Multi-Modality Guidance System because a software anomaly causes an incorrect grid overlay to display during Live or Record mode.

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 situation where use of the product may cause temporary or medically reversible adverse health consequences. The source text describes a software anomaly affecting display accuracy but does not report any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity score.

Plain-English summary

Boston Scientific Corporation is recalling 15 units of the AVVIGO+ Multi-Modality Guidance System (Material Number H7492493320I0, GTIN/UDI/DI 00191506033354). The recall is limited to specific serial numbers: 103810801, 103811529, 103824292, 103826195, 103882483, 103961608, 103961637, 104098361, 104098367, 104108403, 104927614, 104927862, 104930144, 104931985, and 105342419. The affected devices were distributed nationwide in the United States and in Puerto Rico.

The recall was initiated after Boston Scientific received reports that the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the system in Live or Record mode. An investigation determined that a software anomaly causes a 9-grid mark overlay to be incorrectly displayed instead of the correct 15-grid mark overlay. This error affects the reference depth setting for peripheral catheters, which should be 14.9mm. The anomaly is limited to Live or Record modes; in Review mode, the correct 15-grid mark overlay is displayed and the vessel image is correctly scaled.

Healthcare providers and facilities using the AVVIGO+ Multi-Modality Guidance System should check their inventory for the affected serial numbers. If a device is affected, it should be removed from service and returned to Boston Scientific for repair or replacement. No specific instructions for end-users are provided in the source text, as this is a professional medical device.

The recalled product

Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM 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 which inc
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Imaging System
Hazard
Affected units
15

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 (17)

  • Material Number H7492493320I0
  • GTIN/UDI/DI 00191506033354
  • Batch/Serial Numbers: 103810801
  • 103811529
  • 103824292
  • 103826195
  • 103882483
  • 103961608
  • 103961637
  • 104098361
  • 104098367
  • 104108403
  • 104927614
  • 104927862
  • 104930144
  • 104931985
  • 105342419

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 anomaly

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