The Recall Desk
ModerateFDA (Devices)·Z-0103-2025·Announced 2024-10-23

Boston Scientific Recalls AVVIGO+ Guidance System Due to Software Anomaly

Boston Scientific is recalling 14 units of the AVVIGO+ Multi-Modality Guidance System due to a software anomaly that displays an incorrect grid overlay 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 hazard is a software display error that does not involve a physical defect or reported injury, fitting the Moderate severity criteria for low-risk technical issues.

Plain-English summary

Boston Scientific Corporation is recalling 14 units of the AVVIGO+ Multi-Modality Guidance System, specifically the AVVIGO + MOB SYSTEM - ZERO COST US configuration. The recall is due to a software anomaly identified during an investigation into 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.

The anomaly causes a 9-grid mark overlay to be incorrectly displayed during Live mode, whereas the correct overlay for this specific catheter is a 15-grid mark overlay. This incorrect display affects the reference depth setting, which should be 14.9mm for peripheral catheters. The issue 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.

The affected units were distributed nationwide in the United States, including Puerto Rico. The recall involves specific serial numbers and material numbers, including Material Number H7492493120CZ0 and GTIN/UDI/DI 00191506040475. Healthcare providers and facilities should contact Boston Scientific for instructions on how to resolve the software anomaly.

The recalled product

Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB 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 whi
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Imaging System
Hazard
Affected units
14

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 (16)

  • Material Number H7492493120CZ0
  • GTIN/UDI/DI 00191506040475
  • Batch/Serial Numbers: 102977628
  • 104021484
  • 104022028
  • 104146755
  • 104667579
  • 104667581
  • 104755556
  • 104797259
  • 104800029
  • 104801609
  • 104833779
  • 105121661
  • 105136549
  • 105139898

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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