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.
Reported: December 10, 2014 Initiated: October 22, 2014 #Z-0482-2015
Product Description
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 for Recall
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
Details
- Recalling Firm
- Stryker Neurovascular
- Units Affected
- 1 unit
- Distribution
- US Distribution to the states of: VA, NH, OH and TX.
- Location
- Fremont, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Stryker Neurovascular. Units affected: 1 unit.
Why was this product recalled? ▼
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 10, 2014. Severity: Moderate. Recall number: Z-0482-2015.
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