Boston Scientific Corporation: Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570

Is my product affected?

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

• UPC 08714729058410
• UPC 08714729067986
• UPC 08714729068020

Check against the official notice below — it lists the full affected range.

What happened

Boston Scientific Corporation is recalling Contour VL Variable Length Ureteral Stents due to trace amounts of metallic nickel debris found on the stents during the manufacturing process. The recall affects 458 units distributed nationwide in the US and in Japan across multiple lot numbers.

The source document does not specify a remedy for this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel. Distribution: Distribution US nationwide and Japan. Quantity: 458 units Lot/code info: 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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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All FDA (Device enforcement) recalls