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Recall Observatory FDA recall evidence

Device product

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

Z-3020-2018

June 05, 2018

Class II

Product summary

Firm
Stryker Neurovascular
Event
Event 80204
Status
Terminated
Classification
Class II
Quantity
11585
Official record key
device-enforcement:Z-3020-2018

Official wording

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

Code information: All lots.

Distribution pattern: China

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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