FDA Device recall Z-0109-2025
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US
- FDA Device
- Class II
- ongoing
- Published 2024-10-23
On 2024-10-23 the FDA classified a Class II recall of Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US by Boston Scientific, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0109-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-05 |
| Published | 2024-10-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Material Number H7492493120C0, GTIN/UDI/DI 00191506033125, Batch/Serial Numbers: 102724831, 102736254, 102739481, 1027…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, 10414 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0109-2025%22
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