Boston Scientific Recalls ELUVIA Drug-Eluting Vascular Stent System Due to Packaging Error
Boston Scientific is recalling 27 units of the ELUVIA Drug-Eluting Vascular Stent System because some 6x40mm stents were incorrectly placed in 6x100mm packaging.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a packaging error (mislabeling of size) rather than a defect in the stent itself, and no injuries or illnesses are reported in the source text.
Plain-English summary
Boston Scientific Corporation is recalling 27 units of the ELUVIA Drug-Eluting Vascular Stent System. The recall is due to a packaging error where some 6x40mm ELUVIA stents were incorrectly placed into 6x100mm packaging.
The affected product is indicated for improving luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery. The specific lot number is 25838357. The product was distributed nationwide in the United States, including the states of AL, AR, AZ, CA, DE, HI, IL, KS, KY, MA, MD, NC, NJ, NV, NY, OH, OK, PA, PR, TX, VA, WA, and WV.
Healthcare providers and facilities should check their inventory for the affected lot number and stop using the product. Consumers who have had this device implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters (RVD)…
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Vascular Stent
- Affected units
- 27
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)
- LOT: 25838357
Distribution
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