Recall Z-3020-2018— Stryker Neurovascular
Class II · Terminated
Class II FDA medical device recall by Stryker Neurovascular, initiated 2018-06-05, terminated 2020-11-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200, M003WE0450200. Reason: Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported.
- Recalling firm
- Stryker Neurovascular
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-05
- Terminated
- 2020-11-30
- Firm location
- Fremont, CA, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.