Z-3020-2018Class II

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

Name: Z-3020-2018 Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090...
Creator: Stryker Neurovascular
Published: 2018-06-05
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2018-06-05 / Terminated

FDA source

Stryker Neurovascular began a recall of Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150... on 2018-06-05. FDA classified it as Class II and gives the reason as "Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3020-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-05
Posted: 2018-09-07
Terminated: 2020-11-30
Recalling firm: Stryker Corp.
Product: Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200, M003WE0450200
Product code: NJE Intracranial Neurovascular Stent
Reason for recall: Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported
FDA root cause: Use error
Action: On 06/05/2018 Urgent Medical Device Voluntary Customer Notification letters were sent to consignees via courier restating information present in the Directions for Use and additional information. Consignees were instructed to complete Acknowledgement Forms acknowledging receipt and review of the customer notification.
Quantity in commerce: 11585
Distribution: China
Product codes and lots: All lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3020-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3020-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-07

Product code NJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)