FDA Device recall Z-0102-2025
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST JAPAN
- 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 - ZERO COST JAPAN 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-0102-2025 |
| 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 - ZERO COST JAPAN; 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 H7492493220CZ0, GTIN/UDI/DI 00191506040482, Batch/Serial Numbers: 102991580, 102991581, 103044290, 103…Material Number H7492493220CZ0, GTIN/UDI/DI 00191506040482, Batch/Serial Numbers: 102991580, 102991581, 103044290, 103044291, 103044574, 103044577, 103045131, 103046258, 103049558, 103082231, 103082236, 103083046, 103138559, 103161660, 103161661, 103162801, 103163114, 103163116, 103163310, 103163312, 103426739, 103426983, 103460621, 103460622, 103542656, 103554562, 103565449, 103578369, 103648168, 103648304, 103649576, 103652219, 103652220, 103652529, 103652531, 103679467, 103679469, 103679552, 103679554, 103680003, 103683853, 103683854, 103729193, 103729194, 103732842, 103732843, 103754686, 103755483, 103755485, 103770200, 103770201, 103770291, 103770310, 103770451, 103770452, 103770453, 103770454, 103782346, 103782396, 103782397, 103782503, 103782581, 103782582, 103784279, 103798726, 103799816, 103801787, 104075451, 104075673, 104079162, 104082341, 104086595, 104086597, 104086599, 104227518, 104227521, 104228853, 104228854, 104237508, 104237509, 104237585, 104237588, 104238628, 1042 |
|---|
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-0102-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.