Boston Scientific AVVIGO+ Multi-Modality Imaging System Grid Overlay Display Error
Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software error that displays incorrect 9-grid marks instead of 15-grid marks in Live and Record modes. This display error could affect physicians' ability to set proper reference depths during intravascular 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 medical device recall involves a software anomaly causing incorrect display of reference markers during imaging procedures. No illnesses or injuries have been reported, and the hazard is theoretical—an FDA Class II recall without adverse events where a display error could affect clinical decision-making but has not yet resulted in reported harm.
Plain-English summary
Boston Scientific is recalling the AVVIGO+ Multi-Modality Guidance System due to a software anomaly affecting grid mark overlay display. When connected to an OptiCross 18 Peripheral Imaging Catheter, the system incorrectly displays a 9-grid mark overlay instead of the correct 15-grid mark overlay in Live and Record modes. The 15-grid overlay is the proper display for peripheral imaging catheters and allows physicians to set the appropriate reference depth of 14.9mm.
The display 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. A total of 197 units are affected, distributed nationwide including Puerto Rico. Affected devices carry Material Number H7492493120I0 and are identified by specific serial numbers provided by Boston Scientific.
No illnesses or injuries have been reported related to this display error. The incorrect grid overlay in Live mode could prevent physicians from accurately setting reference depths during intravascular imaging procedures. Affected healthcare facilities should verify their device serial numbers and contact Boston Scientific for corrective instructions.
The recalled product
- Product
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; 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
- Manufacturer
- Boston Scientific Corporation
- Hazard
- software-anomaly
- display-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 H7492493120I0
- GTIN/UDI/DI 00191506033163
- Batch/Serial Numbers: 102672283
- 102672284
- 102672368
- 102672369
- 102672371
- 102672447
- 102672449
- 102672450
- 102697688
- 102763844
- 102770998
- 102770999
- 102780704
- 102783352
- 102783523
- 102783889
- 102789480
- 102789481
Distribution
Distributed nationwide across the United States.
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