Boston Scientific AVVIGO+ Imaging System Grid Display Overlay Error
Boston Scientific is recalling 5 units of its AVVIGO+ Guidance System due to a software error that displays an incorrect grid overlay when connected to OptiCross 18 Peripheral Imaging Catheters in Live or Record mode.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a cardiac guidance system with a software display anomaly affecting imaging overlay accuracy. No patient injuries or illnesses reported, classifying this as a risk-of-harm medical device product where injury has not yet been reported per severity rubric criteria.
Plain-English summary
The Boston Scientific AVVIGO+ Multi-Modality Guidance System is a medical device used in cardiac and vascular procedures to display imaging guidance information to physicians. The system provides anatomical and physiologic information, including intravascular ultrasound imaging when used with peripheral vascular imaging catheters.
A software anomaly causes an incorrect grid mark overlay to display on cross-sectional imaging when an OptiCross 18 Peripheral Imaging Catheter is connected to the AVVIGO+ system in Live or Record mode. The system displays a 9-grid overlay instead of the correct 15-grid overlay for peripheral catheters. The correct 15-grid overlay allows for the proper reference depth setting of 14.9mm for peripheral catheters.
The software error is limited to Live and Record modes; in Review mode, the correct 15-grid overlay displays properly and vessel images are correctly scaled. Five units of AVVIGO+ are affected by this software anomaly and have been distributed nationwide in the United States and Puerto Rico.
The recalled product
- Product
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; 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
- Hazard
- display-error
- software-defect
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 (7)
- Material Number H7492493221IZ0
- GTIN/UDI/DI 00191506047443
- Batch/Serial Numbers: 102971349
- 102971350
- 103223891
- 103441162
- 103472760
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03