Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200, M003WE0450200
Reported: September 19, 2018 Initiated: June 5, 2018 #Z-3020-2018
Product Description
Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200, M003WE0450200
Reason for Recall
Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported
Details
- Recalling Firm
- Stryker Neurovascular
- Units Affected
- 11585
- Distribution
- China
- Location
- Fremont, CA
Frequently Asked Questions
What product 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. Recalled by Stryker Neurovascular. Units affected: 11585.
Why was this product recalled? ▼
Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 19, 2018. Severity: Moderate. Recall number: Z-3020-2018.
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