Boston Scientific Recalls Contour VL Ureteral Stent Sets Due to Nickel Debris
Boston Scientific is recalling 458 Contour VL Variable Length Ureteral Stent Sets because trace amounts of nickel debris were found on the devices during manufacturing.
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: The recall involves a medical device with a risk of harm (metallic debris) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Boston Scientific Corporation is recalling 458 units of the Contour VL Variable Length Ureteral Stent Set. The affected products are identified by specific GTINs and lot numbers, including lots 25928323, 25928324, 25928325, 25928326, 25933063, 25933064, 25933065, 25965814, and 25966020.
The recall was initiated because trace amounts of metallic debris were found on the stents related to the manufacturing process. The debris was confirmed to be particles of nickel. The products were distributed in the United States nationwide and in Japan.
Healthcare providers and patients should check their inventory and patient records for these specific lot numbers. If the affected stents are in use, providers should contact Boston Scientific for instructions on replacement or removal.
The recalled product
- Product
- Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 458
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 (5)
- GTIN 08714729423768: Lots 25928323
- 25928324. GTIN 08714729423829: Lots 25928325
- 25928326
- 25933063
- 25933064
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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