Boston Scientific AVVIGO+ Multi-Modality Guidance System Grid Display Software Defect
Boston Scientific is recalling the AVVIGO+ Guidance System for a software defect that displays incorrect grid overlays when connected to OptiCross 18 catheters. The error affects Live and Record modes only; no injuries have been reported.
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 FDA Class II medical device recall involves a software display defect that presents a risk of diagnostic error through incorrect grid overlay display. However, no illnesses, injuries, or adverse events have been reported, placing it in the High rather than Severe category per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Boston Scientific Corporation is recalling the AVVIGO+ Multi-Modality Guidance System, a medical device used by physicians to view real-time anatomical images during intracardiac and intravascular procedures. The system includes an interactive display for examining blood vessels. Six units have been recalled due to a software display defect.
When an OptiCross 18 Peripheral Imaging Catheter is connected to the AVVIGO+ system in Live or Record mode, a software anomaly causes the system to display an incorrect 9-grid mark overlay instead of the correct 15-grid mark overlay. The correct 15-grid overlay is required to provide accurate reference depth settings of 14.9mm for peripheral catheters. The defect does not occur in Review mode, where the correct overlay displays normally.
The recalled units were distributed nationwide in the United States, including Puerto Rico. No illnesses or injuries have been reported in connection with this defect. Healthcare facilities using this equipment should be aware of this display error when using Live or Record modes.
The recalled product
- Product
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various…
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 6
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 (8)
- Material Number H7492493120DZ0
- GTIN/UDI/DI 00191506033156
- Batch/Serial Numbers: 102856880
- 102994713
- 103058232
- 103468307
- 103542491
- 103638657
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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