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Recall Observatory FDA recall evidence

Device product

Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570

Z-0757-2021

November 16, 2020

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 86880
Status
Ongoing
Classification
Class II
Quantity
458 units
Official record key
device-enforcement:Z-0757-2021

Official wording

Reason: Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

Code information: 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, 25809481, 25822104. GTIN 08714729068020: Lots 25578740, 25583824.

Distribution pattern: Distribution US nationwide and Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.