Boston Scientific AVVIGO+ Guidance System Recalled for Grid Overlay Display Error
Boston Scientific is recalling AVVIGO+ systems due to a software anomaly that displays an incorrect grid overlay when connected to OptiCross 18 catheters, potentially leading to vessel imaging misinterpretation.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is a display error in critical imaging software that could lead to diagnostic misinterpretation during vascular procedures, qualifying as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific is recalling 58 units of its AVVIGO+ Multi-Modality Guidance System. A software anomaly causes the system to incorrectly display a 9-grid mark overlay during Live or Record mode when connected to an OptiCross 18 Peripheral Imaging Catheter. The correct overlay for this catheter is the 15-grid mark, which provides a reference depth setting of 14.9mm for peripheral imaging. The incorrect overlay could lead to misinterpretation of vessel images during clinical procedures.
The anomaly affects only Live and Record modes; in Review mode, the system displays the correct 15-grid overlay and properly scales vessel images. The affected units (Material Number H7492493320C0) were distributed nationwide in Puerto Rico.
Physicians using affected systems should discontinue use of this system with OptiCross 18 catheters in Live or Record mode until a corrected version is available. Contact Boston Scientific for support and software updates.
The recalled product
- Product
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; 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
- 58
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 H7492493320C0
- GTIN/UDI/DI 00191506033309
- Batch/Serial Numbers: 103189853
- 103416434
- 103416437
- 103416600
- 103416629
- 103416630
- 103416690
- 103469208
- 103552000
- 103552353
- 103645606
- 103645607
- 103667250
- 103710560
- 103711075
- 103799547
- 104033389
- 104035234
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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