FDA Enforcement
Class II
Terminated
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.
Recall: Z-0482-2015
·
Reported December 10, 2014
Enforcement
- Recall Number
- Z-0482-2015
- Event ID
- 69669
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker Neurovascular
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 10, 2014
- Initiation Date
- October 22, 2014
- Classification Date
- November 28, 2014
- Termination Date
- February 12, 2015
- Address
- 47900 Bayside Pkwy, N/A, Fremont, CA, 94538-6515, United States
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
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
Code Info
Model M00320072209270, Lot number: 12693091; Exp. Jun 2012.
Distribution
US Distribution to the states of: VA, NH, OH and TX.
Quantity
1 unit