Z-0115-2025Class II

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN; the system...

Name: Z-0115-2025 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN; the system...
Creator: Boston Scientific Corporation
Published: 2024-09-05
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2024-09-05 / Open, Classified / root cause: software

FDA source

Boston Scientific Corporation began a recall of Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN; the system utilizes an interactive display to provide... on 2024-09-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0115-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-05
Posted: 2024-10-16
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE 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.
Product code: DQK Computer, Diagnostic, Programmable
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.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: Boston Scientific issued a Product Advisory notice to its consignees beginning on 09/05/2024 via mail, email or hand delivery. The notice explained the problem with the device, clinical impact, and provided recommendations for safe usage until a software update is available to address the anomaly. Boston Scientific is developing a software update to address this anomaly. The consignees were directed to immediately post this product advisory in a visible location near the AVVIGO+ Multi-Modality Guidance System to ensure this information is easily accessible to users. Also, share this product advisory with any health care professional within your organization that needs to be aware and/or with any organization where the affected devices have been transferred (if appropriate). If you are a distributor, this product advisory must be forwarded to your customers to ensure notification of this product advisory is carried out to the end-user level.
Quantity in commerce: 4 units
Distribution: US Nationwide distribution in Puerto Rico.
Product codes and lots: Material Number H7492493221C0, GTIN/UDI/DI 00191506033286, Batch/Serial Numbers: 103034438, 103198701, 104179696, 104910962

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0115-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0095-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0096-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0097-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0098-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0099-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0100-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0101-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0102-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0103-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0104-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0105-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0106-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0107-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0108-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0109-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0110-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0111-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0112-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0113-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0114-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0115-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16
Z-0116-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16

Product code DQK

K230884Class IIAVVIGO'+ Multi-Modality Guidance SystemBoston Scientific Corporation / cleared 2023-09-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)