Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200, M003WE0450200
This recall has been terminated (originally issued June 5, 2018).
- Company
- Stryker Neurovascular
- Recall Initiated
- June 5, 2018
- Terminated
- November 30, 2020
- Recall Number
- Z-3020-2018
- Quantity
- 11585
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported
Distribution
China
Lot / Code Info
All lots.
Root Cause
Use error
Action Taken
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.
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