Reported Oct 23, 2024 · Ongoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- 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.
- Lot codes and dates
Material Number H7492493120C0GTIN/UDI/DI 00191506033125
- Batch/Serial Numbers
161 of 161 codes
102724831102736254102739481102739533102739635102739691102747478102748619102752007102752009102752010102752395102763175102857045102857046102857638102858984102859728102860593102872633102872634102872636102874718102900356102910971102911356102918713102927927102928248102928827102932993102932994102933234102934052102934075102948699102948700102958074102970652102971466102978508102980261102980262102988595102990008103083371103083462103099539103099543103114508103115704103119356103127420103127696103131270103166819103166957103167771103187219103208658
- Amount recalled
- 161 units
This recall covers 22 products
The agency filed one notice per product. You are reading one of them; the other 21 are below.
9 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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