Boston Scientific Recalls VICI RDS Venous Stent System Due to Migration
Boston Scientific is recalling VICI RDS Venous Stent Systems manufactured between May 2018 and April 2021 due to 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 recall is classified as FDA Class I, which mandates a severity score of at least 4 according to the rubric, as it involves a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Boston Scientific Corporation is recalling the VICI RDS Venous Stent System, a medical device indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. The recall covers 34,248 units distributed worldwide and nationwide in the US.
The firm initiated the recall after receiving reports of stent migration following implantation. The affected units are all batches and lots of the device manufactured between May 2018 and April 2021.
Patients who have had this device implanted should contact their healthcare provider for evaluation and guidance regarding the reported issue.
The recalled product
- Product
- VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Vascular Stent
- Hazard
- Affected units
- 34,248
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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