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U.S. Department of Health and Human Services

Class 2 Device Recall Intracranial Neurovascular Stent

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 Class 2 Device Recall Intracranial Neurovascular Stentsee related information
Date Initiated by FirmJune 05, 2018
Create DateSeptember 07, 2018
Recall Status1 Terminated 3 on November 30, 2020
Recall NumberZ-3020-2018
Recall Event ID 80204
HDE NumberH050001 
Product Classification intracranial neurovascular stent - Product Code NJE
ProductWingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200, M003WE0450200
Code Information All lots.
FEI Number 3008853977
Recalling Firm/
Manufacturer		 Stryker Neurovascular
47900 Bayside Pkwy
Fremont CA 94538-6515
Manufacturer Reason
for Recall		Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported
FDA Determined
Cause 2		Use error
ActionOn 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.
Quantity in Commerce11585
DistributionChina
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
HDE DatabaseHDEs with Product Code = NJE
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