Boston Scientific Recalls Contour VL Ureteral Stents Due to Nickel Debris
Boston Scientific is recalling 458 Contour VL Variable Length Ureteral Stents because trace amounts of nickel particles were found on the devices.
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 (nickel exposure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Boston Scientific Corporation is recalling 458 units of the Contour VL Variable Length Ureteral Stent. The affected products include specific lots identified by GTINs 08714729058410, 08714729067986, and 08714729068020. These devices were distributed in the United States and Japan.
The recall was initiated because trace amounts of metallic debris were found on the stents, which was confirmed to be particles of nickel. This issue is related to the manufacturing process.
Healthcare providers and patients should check their inventory and patient records for the specific lot numbers listed in the recall notice. If a patient has received one of these stents, they should contact their healthcare provider for further instructions.
The recalled product
- Product
- Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Urological
- 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 (20)
- GTIN 08714729058410: Lots 25578577
- 25598812
- 25609220
- 25614542
- 25614545
- 25619687
- 25641771
- 25713852
- 25753933
- 25790349. GTIN 08714729067986: Lots 25640715
- 25670518
- 25686790
- 25686791
- 25686792
- 25741763
- 25741770
- 25753937
- 25790351
- 25795704
- 25802759
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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