Boston Scientific AVVIGO+ Guidance System Grid Mark Overlay Defect
Boston Scientific is recalling the AVVIGO+ Multi-Modality Guidance System due to a software defect that displays an incorrect 9-grid mark overlay instead of the correct 15-grid mark overlay when used with OptiCross 18 Peripheral Imaging 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 an FDA Class II recall involving a software display defect that provides incorrect reference information to physicians. The source text does not report any hospitalizations, injuries, or illnesses; the hazard is informational/operational rather than causing direct patient harm, qualifying it as a moderate-severity issue per the rubric.
Plain-English summary
Boston Scientific Corporation is recalling the AVVIGO+ Multi-Modality Guidance System due to a software anomaly affecting grid mark overlay display. When an OptiCross 18 Peripheral Imaging Catheter is connected to the system while in Live or Record mode, the system incorrectly displays a 9-grid mark overlay instead of the correct 15-grid mark overlay. The correct 15-grid overlay allows for proper reference depth settings of 14.9mm for peripheral catheters.
The software anomaly is limited to Live and Record modes. In Review mode, the system correctly displays the 15-grid mark overlay and scales the vessel image appropriately. Eight units with the following serial numbers were distributed nationwide in the US and Puerto Rico: 102899658, 103225132, 103246673, 103647916, 104043675, 104072168, 104258818, and 104512059 (Material Number H7492493120D0).
Patients and healthcare providers using this equipment should be aware of this display anomaly when using the system in Live or Record mode with OptiCross 18 Peripheral Imaging Catheters. Contact Boston Scientific for further guidance on this recall.
The recalled product
- Product
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL 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…
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 8
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 (10)
- Material Number H7492493120D0
- GTIN/UDI/DI 00191506033149
- Batch/Serial Numbers: 102899658
- 103225132
- 103246673
- 103647916
- 104043675
- 104072168
- 104258818
- 104512059
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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