Boston Scientific Medical Device Software Error Affects Vessel Imaging Display
The Boston Scientific AVVIGO+ Guidance System displays an incorrect grid overlay when used with the OptiCross 18 catheter in Live or Record mode, potentially affecting depth reference settings. No injuries have been reported.
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 device with a software defect affecting medical imaging guidance display. No injuries or adverse events have been reported, placing this at the High severity level as a risk-of-harm product without demonstrated harm per the rubric.
Plain-English summary
The Boston Scientific AVVIGO+ Multi-Modality Guidance System is subject to a Class II recall due to a software defect affecting the display of grid mark overlays used for vessel imaging guidance.
When the AVVIGO+ system is connected to an OptiCross 18 Peripheral Imaging Catheter and operated in Live or Record mode, the system incorrectly displays a 9-grid mark overlay instead of the correct 15-grid mark overlay. The 15-grid overlay is necessary to provide physicians with accurate reference depth settings of 14.9mm for peripheral vascular imaging examinations. The software defect does not affect the Review mode, where the correct 15-grid overlay and proper image scaling are displayed.
The recall affects 5 units with material number H7492493220IZ0 distributed nationwide in the United States and Puerto Rico. Affected units are identified by batch/serial numbers 102929196, 102929197, 103224212, 103900781, and 103900804.
No injuries or adverse events related to this defect have been reported. Boston Scientific Corporation is coordinating with healthcare facilities using these devices to address the grid display issue.
The recalled product
- Product
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST 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
- Hazard
- software-defect
- display-error
- incorrect-depth-reference
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 H7492493220IZ0
- GTIN/UDI/DI 00191506033279
- Batch/Serial Numbers: 102929196
- 102929197
- 103224212
- 103900781
- 103900804
Distribution
Distributed nationwide across the United States.
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