FDA Device recall Z-0482-2015
Gateway OTW 2.75mm x 9mm
- FDA Device
- Class II
- terminated
- Published 2014-12-10
On 2014-12-10 the FDA classified a Class II recall of Gateway OTW 2.75mm x 9mm by Stryker Neurovascular, citing units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0482-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-22 |
| Published | 2014-12-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Neurovascular |
| Distribution | NH, OH, TX, VA |
Product
Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion.
Reason
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
Identifiers
| code_info | Model M00320072209270, Lot number: 12693091; Exp. Jun 2012. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0482-2015%22
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