Z-3020-2018 Class II Terminated
FDA device recall Z-3020-2018 was initiated by Stryker Neurovascular on Jun 5, 2018 and is designated Class II. Reason for recall: Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported The recall status is terminated (terminated Nov 30, 2020). Affected quantity: 11585.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 19, 2018
- Initiation Date
- Jun 5, 2018
- Termination Date
- Nov 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11585
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
Distribution Pattern
China
Code Information
All lots.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3020-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026