Reported Sep 19, 2018 · Terminated

Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090,…

Stryker Neurovascular

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: Stryker Neurovascular · 47900 Bayside Pkwy · Fremont, CA · 94538-6515

Is this the product you have?

    • Wingspan Stent System
    • Rx Only
    • Sterile EO
    • Catalog #: M003WE0250090
    • M003WE0300090
    • M003WE0350090
    • M003WE0400090
    • M003WE0450090
    • M003WE0250150
    • M003WE0300150
    • M003WE0350150
    • M003WE0400150
    • M003WE0450150
    • M003WE0250200
    • M003WE0300200
    • M003WE0350200
    • M003WE0400200
    • M003WE0450200
Lot codes and dates
  • All lots.
Amount recalled
11585

Why it was recalled

Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 30, 2020 · Data as of Sep 19, 5:29 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.