AVVIGO+ Multi-Modality Guidance System software defect causes incorrect grid display
Boston Scientific recalled the AVVIGO+ Multi-Modality Guidance System because a software defect causes incorrect grid display in Live and Record modes, potentially affecting vessel imaging guidance for physicians using OptiCross 18 catheters.
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 medical device with no reported hospitalizations, injuries, or illnesses. The hazard is a software defect causing incorrect imaging display in a safety-critical cardiovascular guidance system, but no actual harm has been reported, placing it at most a 3 per the rubric.
Plain-English summary
Boston Scientific has recalled the AVVIGO+ Multi-Modality Guidance System due to a software defect affecting its interactive display. When an OptiCross 18 Peripheral Imaging Catheter is connected to the AVVIGO+ system in Live or Record mode, the grid mark overlay on the cross-sectional view displays incorrectly.
The software defect causes a 9-grid mark overlay to display instead of the correct 15-grid mark overlay during Live mode. The correct 15-grid mark overlay provides a reference depth setting of 14.9 mm for peripheral catheters. The incorrect display also results in improper vessel image scaling.
In Review mode, the system displays the correct 15-grid mark overlay with proper vessel image scaling. The defect is limited to Live and Record modes.
Two units were distributed nationwide, including in Puerto Rico.
The recalled product
- Product
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities whi
- Manufacturer
- Boston Scientific Corporation
- Hazard
- software-defect
- display-error
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 (4)
- Material Number H7492493120IZ0
- GTIN/UDI/DI 00191506033187
- Batch/Serial Numbers: 103060348
- 103060349
Distribution
Distributed nationwide across the United States.
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