medical Class II Updated 2024-10-23

Boston Scientific Corporation recalls Boston Scientific AVVIGO+ Multi-Modality Guidance System, AV

Recalled Product

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB 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 which includes intravascular ultrasound (IVUS). When used with a peripheral vascular imaging catheter, the system utilizes the IVUS modality for ultrasound examination of intravascular pathology.

Hazard / Issue

Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined that, due to a software anomaly, a 9-grid mark overlay is incorrectly displayed during Live mode when AVVIGO+ is connected to an OptiCross 18 Peripheral Imaging Catheter. Note that the correct overlay display for this catheter is the 15-grid mark overlay, which allows for a reference depth setting of 14.9mm for peripheral catheters. This software anomaly is limited to Live or Record mode. In Review mode, the correct 15-grid mark overlay is displayed, and the vessel image is correctly scaled to the appropriate size.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Material Number H7492493221CZ0, GTIN/UDI/DI 00191506047436, Batch/Serial Numbers: 102991870, 102991872, 102991873, 102991874, 103004336, 103004337, 103004339, 103004340, 103006963, 103006965, 103006966, 103007173, 103007176, 103007177, 103007178, 103007380, 103007481, 103007583, 103007584, 103014566, 103014567, 103014569, 103014571, 103017674, 103017675, 103017676, 103017680, 103033749, 103033751, 103034435, 103034436, 103034437, 103036108, 103036122, 103036123, 103036124, 103045960, 103208294, 103208295, 103208297, 103208298, 103416751, 103416752, 103416786, 103416788, 103426736, 103426742, 103426744, 103426745, 103427294, 103427295, 103427297, 103427334, 103427577, 103428138, 103428141, 103428142, 103428143, 103430679, 103430680, 103430681, 104069643, 104069644, 104083192, 104083195, 104083196, 104085311, 104085312, 104085313, 104085314, 104085316, 104085317, 104159043, 104179572, 104179659, 104179664, 104179687, 104179688, 104179690, 104179693, 104179695, 104179706, 104179715, 104179985, 104902848, 104902849, 104903242, 104907814, 104910955, 104910956, 104911201, 104926930
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