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Lower risk Medical device recall · FDA · Published November 16, 2020

Boston Scientific Contour VL Stent Recall: Nickel Debris Hazard

Boston Scientific recalls Contour VL Variable Length Ureteral Stent Sets with nickel debris from manufacturing. Affected units include specific model numbers and production lots. Consumers should contact the company for details.

🇺🇸 FDA recall #Z-0758-2021Medical deviceBoston Scientific ›
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Contact the company

Recalling firmBoston Scientific Corporation300 Boston Scientific Way · Marlborough, MA 01752-1291
✎ GovInfoNow plain-language explainer

What happened, in plain English

Boston Scientific is recalling certain Contour VL Variable Length Ureteral Stent Sets due to trace nickel debris found during manufacturing. This could cause allergic reactions or irritation in some users, though serious injury risks are not specified in the recall. Read more at govinfonow.com/recall/63909-boston-scientific-contour-vl-stent-recall-nickel-debris-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/63909-boston-scientific-contour-vl-stent-recall-nickel-debris-hazard · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0758-2021

Cite this page

“Boston Scientific Contour VL Stent Recall: Nickel Debris Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63909-boston-scientific-contour-vl-stent-recall-nickel-debris-hazard. Based on FDA recall #Z-0758-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0758-2021%22&limit=1).

Why it’s dangerous

The stent contains trace amounts of nickel debris from the manufacturing process. This debris could cause allergic reactions or irritation in individuals sensitive to nickel, though the recall does not mention serious injury risks.

Who’s affected

People who own or use the recalled Contour VL Variable Length Ureteral Stent Sets with the listed model numbers and production lots are affected. Those with nickel allergies may be at higher risk of irritation.

How to tell if you have this one

Check for the model numbers: UPN M006180155090, M006180156090, M006180156180, M006180156190. Also look for the production lots listed in the GTIN codes.

  • Brand
    Boston Scientific
  • Product
    Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Distribution US nationwide and Japan.
Recall numberProduct, codes & lots
Z-0757-2021Contour 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.
Z-0758-2021Contour 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.
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify your stent model and production lot by checking the product labels or the GTIN numbers provided in the recall.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Distribution US nationwide and Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 51 days after the firm started it.

1. Firm started the recall: Nov 16, 202012. FDA classified it Class II: Dec 30, 202023. Published in FDA’s Enforcement Report: Jan 6, 2021320202021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0758-2021 (November 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0758-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA