Boston Scientific Recalls VICI Venous Stent System Due to Migration Reports
Boston Scientific is recalling VICI Venous Stent Systems because the company received reports of stent migration after implantation.
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: The recall involves a medical device with reported adverse events (stent migration) but no explicit mention of death, serious injury, or FDA Class I classification, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Boston Scientific Corporation is recalling the VICI VENOUS STENT System. The device is intended for the treatment of obstructions and occlusions in the venous vasculature.
The recall was initiated because the firm received reports of stent migration after implantation. The recall covers 550 units of the device. All batches and lots manufactured between May 2018 and April 2021 are affected.
The product was distributed worldwide and nationwide in the United States. The source text does not specify instructions for consumers or healthcare providers regarding the next steps to take.
The recalled product
- Product
- VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 550
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 (1)
- all batches/lots of the device manufactured between May 2018 through April 2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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