Reported Oct 23, 2024 · Ongoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes…
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 II TO AVVIGO + MOB Z UPGRADE JP; 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 H7492493221CZ0GTIN/UDI/DI 00191506047436
- Batch/Serial Numbers
92 of 92 codes
102991870102991872102991873102991874103004336103004337103004339103004340103006963103006965103006966103007173103007176103007177103007178103007380103007481103007583103007584103014566103014567103014569103014571103017674103017675103017676103017680103033749103033751103034435103034436103034437103036108103036122103036123103036124103045960103208294103208295103208297103208298103416751103416752103416786103416788103426736103426742103426744103426745103427294103427295103427297103427334103427577103428138103428141103428142103428143103430679103430680
- Amount recalled
- 92 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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