The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0102-2025·Announced 2024-10-23

Boston Scientific AVVIGO+ guidance system recalled for grid overlay display error

Boston Scientific's AVVIGO+ guidance system is recalled because a software glitch causes an incorrect grid overlay display when used with an OptiCross 18 catheter. The correct overlay appears in Review mode, and no patient 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 2/5 (Moderate).

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: FDA Class II recall with no reported illnesses or injuries. The issue is a software display anomaly affecting grid overlay visualization; the system functions correctly in Review mode, mitigating the risk of incorrect reference depth calculations.

Plain-English summary

Boston Scientific Corporation is recalling 124 units of the AVVIGO+ Multi-Modality Guidance System distributed nationwide in the United States and Puerto Rico. The recall addresses a software anomaly affecting the display of the grid mark overlay.

When an OptiCross 18 Peripheral Imaging Catheter is connected to the AVVIGO+ system in Live or Record mode, the grid mark overlay displays incorrectly as a 9-grid pattern instead of the proper 15-grid pattern. The 15-grid overlay is used to set the correct 14.9mm reference depth for peripheral catheter imaging. The system displays the correct 15-grid overlay and properly scaled vessel images when operating in Review mode.

No patient illnesses or injuries have been reported. Facilities using affected units should contact Boston Scientific for information about the recalled serial numbers and recommendations for device operation or replacement.

The recalled product

Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB 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 — Intravascular Imaging System
Hazard
Affected units
124

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 H7492493220CZ0
  • GTIN/UDI/DI 00191506040482
  • Batch/Serial Numbers: 102991580
  • 102991581
  • 103044290
  • 103044291
  • 103044574
  • 103044577
  • 103045131
  • 103046258
  • 103049558
  • 103082231
  • 103082236
  • 103083046
  • 103138559
  • 103161660
  • 103161661
  • 103162801
  • 103163114
  • 103163116

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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