CLASS II Device recall · Reported 19 Sep 2018 · FDA Enforcement Report

Wingspan Stent System recalled by Stryker Neurovascular

Stryker Neurovascular is recalling Wingspan Stent System. The recall was initiated on 5 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots.

Quantity recalled11585

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3020-2018
FDA event ID: 80204
Recalling firm: Stryker Neurovascular, Fremont, CA
Classification: Class II
Status: Terminated
Recall initiated: 5 Jun 2018
FDA classified: 7 Sep 2018
Reported: 19 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

5 Jun 2018	Recall initiated by company
7 Sep 2018	Classified by FDA	+94 days
19 Sep 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200, M003WE0450200

Where it was distributed

China

Questions about this recall

Why was it recalled?

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

Which lots are affected?

All lots.

Where was it sold?

China

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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