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Unrated Medical device recall · FDA · Published June 5, 2018

Stryker Wingspan Stent System Recall: Use-related coating damage on delivery catheters

Stryker is recalling Wingspan Stent System (Rx Only, Sterile EO) due to reported use-related coating damage on delivery catheter shafts. Affected units have specific catalog numbers. No remedy is stated in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3020-2018Medical deviceStryker Neurovascular ›
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Contact the company

Recalling firmStryker Neurovascular47900 Bayside Pkwy · Fremont, CA 94538-6515
✎ GovInfoNow plain-language explainer

Stryker is recalling certain Wingspan Stent Systems for possible use-related coating damage on delivery catheters. This could affect medical procedures if the coating damage leads to improper function during use. Read more at govinfonow.com/recall/70901-stryker-wingspan-stent-system-recall-use-related-coating-damage-on.

Source Summary by GovInfoNow · govinfonow.com/recall/70901-stryker-wingspan-stent-system-recall-use-related-coating-damage-on · Updated August 20, 2026 · FDA enforcement record: FDA #Z-3020-2018

Cite this page

“Stryker Wingspan Stent System Recall: Use-related coating damage on delivery catheters.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70901-stryker-wingspan-stent-system-recall-use-related-coating-damage-on. Based on FDA recall #Z-3020-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3020-2018%22&limit=1).

The FDA announced on June 5, 2018, that Stryker Neurovascular is recalling its Wingspan Stent System due to use-related coating damage on delivery catheter shafts. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Stryker Neurovascular
  • Product: Wingspan Stent System
  • Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200, M003WE0450200
  • All lots
  • Units affected: 11585

The hazard

The recall addresses use-related coating damage on the delivery catheter shafts of Wingspan delivery catheters, according to FDA records.

Context

GovInfoNow's records show Stryker Neurovascular has 16 other recalls on record since June 26, 2017. Other recent recalls include the Stryker INZONE Detachment System (April 6, 2026), the Stry Trevo Trak 21 Microcatheter (Aug. 30, 2024), and Stryker Trevo Pro Microcatheters (April 23, 2024). Similar recent recalls of other products include the Stryker BARD EP XT Steerable Catheter (April 10, 2026), the Stryker BARD Dynamic Deca Steerable Catheter (April 10, 2026), and the Stryker BARD Dynamic Tip Steerable (April 10, 2026).

How to tell if you have this one

Check for catalog numbers starting with M003WE followed by 0250090, 0300090, 0350090, 0400090, 0450090, 0250150, 0300150, 0350150, 0400150, 0450150, 0250200, 0300200, 0350200, 0400200, or 0450200. All lots of these products are affected.

  • Brand
    Stryker Neurovascular
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Catalog Numbers

    Identify if your Wingspan Stent System has catalog numbers listed in the affected range.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

1. Firm started the recall: Jun 5, 201812. FDA classified it Class II: Sep 7, 201823. Published in FDA’s Enforcement Report: Sep 19, 201834. FDA terminated the recall: Nov 30, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-3020-2018 (June 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3020-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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