Boston Scientific Recalls AVVIGO+ Guidance Systems Due to Software Display Error
Boston Scientific is recalling 40 AVVIGO+ Multi-Modality Guidance Systems because a software anomaly causes an incorrect grid overlay to display during Live or Record mode when used with specific catheters.
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: The recall is classified as FDA Class II, which typically indicates a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences. The issue is a software display error that does not involve a structural defect or reported injuries, fitting the Moderate severity criteria for low-risk technical anomalies.
Plain-English summary
Boston Scientific Corporation is recalling 40 units of the AVVIGO+ Multi-Modality Guidance System (AVVIGO II TO AVVIGO MOB UPGRADE US). The affected devices are distributed nationwide in the United States and in Puerto Rico. The system is used by physicians to provide physiologic, intravascular, and intracardiac anatomical information, including intravascular ultrasound (IVUS) examinations.
The recall is due to a software anomaly identified by Boston Scientific. When an OptiCross 18 Peripheral Imaging Catheter is connected to the system in Live or Record mode, the device incorrectly displays a 9-grid mark overlay instead of the correct 15-grid mark overlay. This error affects the reference depth setting for peripheral catheters. The anomaly is limited to Live and Record modes; in Review mode, the correct 15-grid mark overlay is displayed, and the vessel image is correctly scaled.
Healthcare providers and facilities that have received these specific units should stop using the affected systems for Live or Record mode imaging with the OptiCross 18 Peripheral Imaging Catheter. Boston Scientific has provided specific serial numbers and material numbers to identify the affected units. Users should contact Boston Scientific for further instructions on remediation or replacement.
The recalled product
- Product
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE US; 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 System
- Affected units
- 40
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 H7492493121C0
- GTIN/UDI/DI 00191506033194
- Batch/Serial Numbers: 102946988
- 102946990
- 102949556
- 103199497
- 103199500
- 103199502
- 103207815
- 103207817
- 103207860
- 103439257
- 103439962
- 104233565
- 104233569
- 104233592
- 104260813
- 104278173
- 104284141
- 104322013
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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