Boston Scientific AVVIGO+ Imaging System Grid Display Error
Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software error causing incorrect grid overlay display when used with OptiCross 18 catheters, which could affect measurement accuracy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a medical device software error that could affect measurement accuracy and clinical decision-making, fitting the criterion of 'risk-of-harm products where injury has not yet been reported.' No illnesses or injuries are reported in the source, making the score capped at 3 per the rubric.
Plain-English summary
Boston Scientific Corporation is recalling 9 units of the AVVIGO+ Multi-Modality Guidance System distributed in Puerto Rico and nationwide in the U.S. The system provides physicians with physiologic and intravascular anatomical imaging information during clinical procedures.
A software anomaly causes the system to display an incorrect 9-grid mark overlay when an OptiCross 18 Peripheral Imaging Catheter is connected while the system is in Live or Record mode. The correct display should show a 15-grid mark overlay, which provides the proper reference depth setting of 14.9mm for peripheral catheters. This incorrect display could affect the accuracy of measurements and clinical decision-making.
The error occurs only in Live and Record modes; Review mode displays the correct 15-grid overlay with proper image scaling. Affected units are identified by specific serial numbers including 103045130, 103427062, 103427064, 103460623, 103545307, 103545308, 103679278, 103679281, and 103680004.
The recalled product
- Product
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM 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…
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Material Number H7492493220C0
- GTIN/UDI/DI 00191506033231
- Batch/Serial Numbers: 103045130
- 103427062
- 103427064
- 103460623
- 103545307
- 103545308
- 103679278
- 103679281
- 103680004
Distribution
Part of a larger recall action
This product is one of 22 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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