Device 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.
Z-0482-2015
Product summary
- Event
- Event 69669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0482-2015
Official wording
Reason: Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
Code information: Model M00320072209270, Lot number: 12693091; Exp. Jun 2012.
Distribution pattern: US Distribution to the states of: VA, NH, OH and TX.
Derived failure modes
-
Unknown
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.