The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0096-2025·Announced 2024-10-23

Boston Scientific Medical Device Software Error Affects Vessel Imaging Display

The Boston Scientific AVVIGO+ Guidance System displays an incorrect grid overlay when used with the OptiCross 18 catheter in Live or Record mode, potentially affecting depth reference settings. No injuries have been reported.

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: FDA Class II device with a software defect affecting medical imaging guidance display. No injuries or adverse events have been reported, placing this at the High severity level as a risk-of-harm product without demonstrated harm per the rubric.

Plain-English summary

The Boston Scientific AVVIGO+ Multi-Modality Guidance System is subject to a Class II recall due to a software defect affecting the display of grid mark overlays used for vessel imaging guidance.

When the AVVIGO+ system is connected to an OptiCross 18 Peripheral Imaging Catheter and operated in Live or Record mode, the system incorrectly displays a 9-grid mark overlay instead of the correct 15-grid mark overlay. The 15-grid overlay is necessary to provide physicians with accurate reference depth settings of 14.9mm for peripheral vascular imaging examinations. The software defect does not affect the Review mode, where the correct 15-grid overlay and proper image scaling are displayed.

The recall affects 5 units with material number H7492493220IZ0 distributed nationwide in the United States and Puerto Rico. Affected units are identified by batch/serial numbers 102929196, 102929197, 103224212, 103900781, and 103900804.

No injuries or adverse events related to this defect have been reported. Boston Scientific Corporation is coordinating with healthcare facilities using these devices to address the grid display issue.

The recalled product

Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; 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 — Imaging Guidance System
Hazard
Affected units
5

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 (7)

  • Material Number H7492493220IZ0
  • GTIN/UDI/DI 00191506033279
  • Batch/Serial Numbers: 102929196
  • 102929197
  • 103224212
  • 103900781
  • 103900804

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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