Boston Scientific AVVIGO+ Medical Device Grid Overlay Display Error
Boston Scientific recalls 161 AVVIGO+ Multi-Modality Guidance Systems due to a software error causing an incorrect grid overlay display in Live and Record modes. The error affects measurement reference accuracy during intravascular imaging procedures.
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: This is a FDA Class II device recall with a software display error. No illnesses or injuries are reported. The issue affects the reference grid overlay in Live and Record modes only, while the actual imaging function remains correct with proper display in Review mode.
Plain-English summary
Boston Scientific is recalling 161 units of the AVVIGO+ Multi-Modality Guidance System due to a software display error. The system is used in hospitals and medical facilities to provide physicians with intravascular and intracardiac imaging information during invasive procedures.
Boston Scientific received reports that when an OptiCross 18 Peripheral Imaging Catheter is connected to the AVVIGO+ system, an incorrect 9-grid mark overlay displays during Live and Record modes. The correct overlay for this catheter is the 15-grid mark overlay, which provides the appropriate reference depth setting of 14.9 mm for peripheral vascular measurements.
The software error is limited to Live and Record modes. In Review mode, the AVVIGO+ system displays the correct 15-grid mark overlay and properly scales the vessel image. The underlying vessel imaging data itself is not affected; only the reference grid overlay display is incorrect.
Affected units are identified by Material Number H7492493120C0 and specific batch/serial numbers listed in the recall notice. Healthcare facilities and physicians using affected AVVIGO+ systems should contact Boston Scientific for guidance on corrective actions.
The recalled product
- Product
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes
- Manufacturer
- Boston Scientific Corporation
- Hazard
- display-error
- measurement-reference-error
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 H7492493120C0
- GTIN/UDI/DI 00191506033125
- Batch/Serial Numbers: 102724831
- 102736254
- 102739481
- 102739533
- 102739635
- 102739691
- 102747478
- 102748619
- 102752007
- 102752009
- 102752010
- 102752395
- 102763175
- 102857045
- 102857046
- 102857638
- 102858984
- 102859728
Distribution
Distributed nationwide across the United States.
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