Boston Scientific Recalls AVVIGO+ Guidance System Due to Software Anomaly
Boston Scientific is recalling 4 units of the AVVIGO+ Multi-Modality Guidance System because a software error displays the wrong grid overlay during 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: The recall is classified as FDA Class II, and the source text describes a software display anomaly without reporting any patient injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Boston Scientific Corporation is recalling 4 units of the AVVIGO+ Multi-Modality Guidance System. The recall is limited to units distributed in Puerto Rico. The affected systems are identified by Material Number H7492493221C0, GTIN/UDI/DI 00191506033286, and specific serial numbers: 103034438, 103198701, 104179696, and 104910962.
The recall was initiated after reports indicated that the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the system. A software anomaly causes a 9-grid mark overlay to be incorrectly displayed during Live or Record mode. The correct overlay for this catheter is a 15-grid mark overlay, which allows for a reference depth setting of 14.9mm. The anomaly is limited to Live or Record modes; in Review mode, the correct overlay is displayed and the vessel image is correctly scaled.
Healthcare providers and facilities should check their inventory for the specific serial numbers listed above. If the affected units are in use, they should contact Boston Scientific for instructions on how to proceed.
The recalled product
- Product
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB 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
- Category
- Medical Device — Imaging System
- Affected units
- 4
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 (6)
- Material Number H7492493221C0
- GTIN/UDI/DI 00191506033286
- Batch/Serial Numbers: 103034438
- 103198701
- 104179696
- 104910962
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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