FDA-Device2021-01-06Class II
Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
Boston Scientific Corporation
Hazard
Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.
Sold states
Distribution US nationwide and Japan.
Affected count
458 units
Manufactured in
300 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0758-2021Don't want to check this manually?
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