Boston Scientific imaging system software error in grid overlay display
Boston Scientific AVVIGO+ imaging system has a software error causing incorrect grid overlay display in Live and Record modes, potentially affecting depth reference during vascular procedures. 2 units are recalled.
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 risk-of-harm medical device where imaging accuracy is critical to patient safety during vascular procedures. No injuries or illnesses have been reported, but the software anomaly could lead to improper catheter positioning if physicians rely on the incorrect depth reference in Live or Record modes.
Plain-English summary
Boston Scientific AVVIGO+ Multi-Modality Guidance System is a medical imaging device used to guide vascular procedures. When connected to an OptiCross 18 Peripheral Imaging Catheter and operated in Live or Record mode, the system displays an incorrect 9-grid mark overlay instead of the correct 15-grid mark overlay.
The correct 15-grid mark overlay provides physicians with the appropriate reference depth setting (14.9mm) for peripheral catheters. The incorrect 9-grid overlay could lead to improper depth assessment and catheter positioning during vascular procedures. The software anomaly does not occur in Review mode, where the correct 15-grid overlay displays properly.
The recall affects 2 units (serial numbers 103900407 and 104650692) distributed in the US and Puerto Rico. The issue is specific to use with OptiCross 18 Peripheral Imaging Catheters and does not affect other catheter types or Review mode operation.
The recalled product
- Product
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT 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
- 2
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 (4)
- Material Number H7492493220I0
- GTIN/UDI/DI 00191506033255
- Batch/Serial Numbers: 103900407
- 104650692
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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