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

Agency Publication Date: December 30, 2020

Affected Products

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

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.

Product: Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190

GTIN 08714729423768: Lots 25928323, 25928324. GTIN 08714729423829: Lots 25928325, 25928326, 25933063, 25933064, 25933065. GTIN 08714729772743: Lot 25965814. GTIN 08714729765837: Lot 25966020.

Lot Numbers:

25965814

25966020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86880

Status: Active

Manufacturer: Boston Scientific Corporation

Manufactured In: United States

Units Affected: 2 products (458 units)

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Sources: FDA iRES · Raw API Response

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