Boston Scientific AVVIGO+ System Grid Overlay Display Software Error
Boston Scientific is recalling the AVVIGO+ Multi-Modality Guidance System due to a software error that displays an incorrect 9-grid overlay instead of the correct 15-grid overlay in Live or Record mode, affecting measurement accuracy with OptiCross 18 catheters.
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: FDA Class II device with a confirmed software defect affecting measurement accuracy in clinical guidance. No injuries or illnesses have been reported, but the risk-of-harm is significant as incorrect measurement calibration could compromise clinical decision-making during interventional procedures.
Plain-English summary
Boston Scientific is recalling 92 units of the AVVIGO+ Multi-Modality Guidance System due to a software anomaly that causes incorrect grid overlay display when an OptiCross 18 Peripheral Imaging Catheter is connected in Live or Record mode. The system displays a 9-grid mark overlay when it should display a 15-grid mark overlay. The correct 15-grid overlay allows the appropriate reference depth setting of 14.9mm for peripheral catheters.
The software error occurs only in Live and Record modes. In Review mode, the system correctly displays the 15-grid mark overlay and properly scales the vessel image. Boston Scientific's investigation confirmed that the anomaly is due to a software defect in overlay generation.
This device is used by physicians to provide physiologic, intravascular, and intracardiac anatomical information during interventional procedures. The incorrect grid display could affect measurement calibration and clinical decision-making during real-time imaging. The affected units were distributed nationwide, including in Puerto Rico.
Physicians and healthcare facilities using the affected serial numbers should contact Boston Scientific for instructions on software updates or device replacement. Users should review cases involving affected units to determine any potential impact on clinical outcomes.
The recalled product
- Product
- 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
- Manufacturer
- Boston Scientific Corporation
- Hazard
- software-anomaly
- 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 (20)
- Material Number H7492493221CZ0
- GTIN/UDI/DI 00191506047436
- Batch/Serial Numbers: 102991870
- 102991872
- 102991873
- 102991874
- 103004336
- 103004337
- 103004339
- 103004340
- 103006963
- 103006965
- 103006966
- 103007173
- 103007176
- 103007177
- 103007178
- 103007380
- 103007481
- 103007583
Distribution
Distributed nationwide across the United States.
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