Boston Scientific AVVIGO+ Imaging System Grid Overlay Display Error
A software anomaly in the Boston Scientific AVVIGO+ Multi-Modality Guidance System causes an incorrect grid overlay display when used with certain catheters. The wrong overlay may lead to incorrect measurement references during imaging procedures.
What this means for you
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 Class II device with a software anomaly presenting a risk of incorrect measurement guidance during medical imaging procedures, with no injuries reported. The defect affects measurement accuracy, which could impact clinical decision-making.
Plain-English summary
Boston Scientific has issued a recall of 9 units of the AVVIGO+ Multi-Modality Guidance System due to a software anomaly affecting the grid overlay display.
When an OptiCross 18 Peripheral Imaging Catheter is connected to the AVVIGO+ system in Live or Record mode, the system displays a 9-grid overlay instead of the correct 15-grid overlay. The correct 15-grid overlay allows physicians to set the proper reference depth of 14.9mm for peripheral catheters. This software anomaly could result in incorrect measurement references during imaging procedures.
The issue does not occur in Review mode, where the correct 15-grid overlay displays properly. Affected units are identified by specific serial numbers and were distributed nationwide, including Puerto Rico. Physicians using affected devices should contact Boston Scientific for updated software or device guidance.
The recalled product
- Product
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; 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
- Hazard
- display-error
- measurement-error
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 H7492493150I0
- GTIN/UDI/DI 00191506033224
- Batch/Serial Numbers: 102888346
- 102888349
- 103233723
- 103233724
- 104384572
- 104399815
- 104420529
- 104618017
- 104618220
Distribution
Distributed nationwide across the United States.
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