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Terminated

Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200, M003WE0450200

FDA Recall Z-3020-2018 · Posted None

Recalling FirmStryker Neurovascular
Recall StatusTerminated
Product CodeNJE
Date Initiated2018-06-05
Date Terminated2020-11-30
Product Quantity11585

Reason for Recall

Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported

Firm Action

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.

Root Cause

Use error

Distribution Pattern

China

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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