Recalls / —
—#165206
Product
Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200, M003WE0450200
- FDA product code
- NJE — Intracranial Neurovascular Stent
- Device class
- Class f
- Medical specialty
- Unknown
- Affected lot / code info
- All lots.
Why it was recalled
Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported
Root cause (FDA determination)
Use error
Action the firm took
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.
Recalling firm
- Firm
- Stryker Neurovascular
- Address
- 47900 Bayside Pkwy, Fremont, California 94538-6515
Distribution
- Distribution pattern
- China
Timeline
- Recall initiated
- 2018-06-05
- Terminated
- 2020-11-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #165206. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.