Boston Scientific WallFlex Biliary Stent Mislabeled - Risk of Wrong Product Use
Boston Scientific recalls WallFlex Biliary RX Fully Covered Stent System RMV (10mmx60mm) due to mislabeling as covered when it's uncovered. This could lead to incorrect medical use.
Lower-risk recall
Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device
Contact the company
What happened, in plain English
Boston Scientific is recalling a specific biliary stent system because it's mislabeled as a covered stent when it's actually an uncovered one. Using the wrong type could cause improper treatment or complications during medical procedures. Read more at govinfonow.com/recall/64515-boston-scientific-wallflex-biliary-stent-mislabeled-risk-of-wrong-product.
Source Summary by GovInfoNow · govinfonow.com/recall/64515-boston-scientific-wallflex-biliary-stent-mislabeled-risk-of-wrong-product · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2958-2020
Cite this page
“Boston Scientific WallFlex Biliary Stent Mislabeled - Risk of Wrong Product Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64515-boston-scientific-wallflex-biliary-stent-mislabeled-risk-of-wrong-product. Based on FDA recall #Z-2958-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2958-2020%22&limit=1).
Why it’s dangerous
The stent is labeled as a fully covered type but is actually uncovered. This mislabeling could lead to incorrect medical procedures if the wrong stent is used during treatment for biliary obstructions.
Who’s affected
Patients who received this specific stent system for biliary strictures or obstructions are likely affected. Medical professionals using the product for palliative treatment may also be at risk if they use the wrong stent type.
How to tell if you have this one
Check for the product name 'WallFlex Biliary RX Fully Covered Stent System RMV (10mmx60mm)' with lot code 25607019 and expiration date June 17, 2022. The product is used for palliative treatment of biliary strictures.
- Brand
Boston Scientific- Category
Medical device
What to do — step by step
Check Product Label
Look for the lot code 25607019 and expiration date June 17, 2022 on the stent packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 5 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this stent safe to use?
The recall indicates a mislabeling risk, but the product is not inherently unsafe. Correct use with proper labeling is required for safety.
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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-2958-2020 (August 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2958-2020 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.