Reported Jan 6, 2021 · Ongoing
Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 300 Boston Scientific Way · Marlborough, MA · 01752-1291
Is this the product you have?
Contour VL Variable Length Ureteral StentUPN M0061801550M0061801560M0061801570
- Lot codes and dates
- GTIN 08714729058410
Lots 25578577255988122560922025614542256145452561968725641771257138522575393325790349
- GTIN 08714729067986
Lots 25640715256705182568679025686791256867922574176325741770257539372579035125795704258027592580948125822104
- GTIN 08714729068020
Lots 2557874025583824
- GTIN 08714729058410
- Amount recalled
- 458 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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