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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The firm has received reports of stent migration after implantation"
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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