Stryker Neurovascular recalls Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003…

Recall date

June 5, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3020-2018

FDA classification

Class II

Brand / firm

Stryker Neurovascular

Sold / distributed

China

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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