Medical imaging system software defect causes incorrect grid overlay display
Boston Scientific recalled the AVVIGO+ imaging guidance system due to a software defect that displays a 9-grid overlay instead of the correct 15-grid overlay when connected to OptiCross 18 catheters in Live or Record mode.
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: This is a Class II device recall with no reported illnesses or injuries. Although the software defect affects measurement reference accuracy in cardiac and vascular imaging, a workaround exists through Review mode where the correct overlay displays. The hazard is technical rather than a direct safety failure.
Plain-English summary
Boston Scientific has recalled the AVVIGO+ Multi-Modality Guidance System due to a software defect that affects how the system displays imaging information. When connected to an OptiCross 18 Peripheral Imaging Catheter and operating in Live or Record mode, the system displays a 9-grid mark overlay instead of the correct 15-grid mark overlay. The 15-grid overlay provides the appropriate reference depth setting of 14.9mm needed for accurate measurements in peripheral vascular imaging.
This display defect can affect real-time imaging interpretation by physicians. The correct 15-grid mark overlay and properly scaled images display when the system operates in Review mode, and the system functions normally when used with other imaging catheters. Boston Scientific identified the cause as a software anomaly specific to the combination of Live or Record mode operation with the OptiCross 18 Peripheral Imaging Catheter.
Boston Scientific distributed this system nationwide in the United States, including Puerto Rico. The affected unit is identified by Material Number H7492493221I0 with Batch/Serial Number 103494807.
The recalled product
- Product
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE 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
- Affected units
- 1
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 (3)
- Material Number H7492493221I0
- GTIN/UDI/DI 00191506033293
- Batch/Serial Numbers: 103494807
Distribution
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.
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