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

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 H7492493120C0, GTIN/UDI/DI 00191506033125, Batch/Serial Numbers: 102724831, 102736254, 102739481, 102739533, 102739635, 102739691, 102747478, 102748619, 102752007, 102752009, 102752010, 102752395, 102763175, 102857045, 102857046, 102857638, 102858984, 102859728, 102860593, 102872633, 102872634, 102872636, 102874718, 102900356, 102910971, 102911356, 102918713, 102927927, 102928248, 102928827, 102932993, 102932994, 102933234, 102934052, 102934075, 102948699, 102948700, 102958074, 102970652, 102971466, 102978508, 102980261, 102980262, 102988595, 102990008, 103083371, 103083462, 103099539, 103099543, 103114508, 103115704, 103119356, 103127420, 103127696, 103131270, 103166819, 103166957, 103167771, 103187219, 103208658, 103209501, 103210318, 103210974, 103246763, 103442205, 103442227, 103452461, 103453092, 103484498, 104021165, 104026019, 104026081, 104026383, 104026586, 104031272, 104031297, 104126629, 104146350, 104146352, 104146822, 104146826, 104146831, 104146838, 104146866, 104146871, 104148636, 104148713, 104208177, 104208211, 104208216, 104208868, 104208922, 104219001, 104219647, 104219649, 104221489, 104227135, 104354864, 104371873, 104374276, 104380868, 104384808, 104384911, 104387708, 104397652, 104400093, 104403872, 104404203, 104419880, 104419893, 104419919, 104647863, 104647894, 104650513, 104666682, 104666685, 104673058, 104751209, 104755550, 104771280, 104771287, 104780803, 104781129, 104781136, 104786917, 104788864, 104796967, 104797260, 104798419, 104803143, 104807527, 104808883, 104811360, 104813989, 104814198, 104818951, 104818988, 104819688, 104819702, 104821763, 104825997, 104831952, 104836658, 104836680, 104837178, 104870500, 104871241, 104871255, 104872271, 105107690, 105107695, 105121659, 105128877, 105133223, 105133225, 105136550, 105136911, 105139406, 105139411, 105146694, 105146787