Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; 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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Boston Scientific Corporation
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; 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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0109-2025
Related Recalls
Model Number L211 PROPONENT DR SL MRI Pacemaker
Boston Scientific
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Model Number S702, ALTRUA 2 DR SL Pacemaker
Boston Scientific
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Model Number U128, VALITUDE CRT-P EL MRI
Boston Scientific
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).