Boston Scientific is recalling 790 units of the AVVIGO+ Multi-Modality Guidance System because a software error causes the system to display the wrong measurement grid when used with the OptiCross 18 Peripheral Imaging Catheter. During live or recording modes, the system shows a 9-grid mark overlay instead of the required 15-grid mark overlay, which could lead to incorrect depth measurements and scaling during medical procedures. The system was distributed in the United States and Puerto Rico, and while the error is present during live use, the correct measurements are displayed when reviewing recorded footage.
The software anomaly causes the vessel image to be scaled incorrectly on the screen, which could lead a physician to misinterpret the size or depth of a patient's blood vessel during a procedure. This error poses a risk of incorrect device placement or other surgical complications due to inaccurate visual guidance.
Software assessment and corrective updates
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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