FDAClass IIJanuary 6, 2021

Contour VL Variable Length Ureteral Stent recall

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

Why was Contour VL Variable Length Ureteral Stent recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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, UPN M0061801550, M0061801560, M0061801570
Recalling firm
Boston Scientific Corporation
Quantity
458 units
Distribution
Distribution US nationwide and Japan.
Recall date
January 6, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls