FDA-Device2018-09-19Class II
Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200, M003WE0450200
Stryker Neurovascular
Hazard
Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported
Sold states
China
Affected count
11585
Manufactured in
47900 Bayside Pkwy, N/A, Fremont, CA, United States
Products
Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200, M003WE0450200
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3020-2018Don't want to check this manually?
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