Z-0655-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 16, 2013
- Initiation Date
- December 20, 2012
- Termination Date
- February 5, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units
Product Description
FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A balloon is flush mounted on the distal end. FlowGate" Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.
Reason for Recall
Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration.
Distribution Pattern
US (nationwide) including the states of CA, FL, GA, OR and TN.
Code Information
Catalog number 90253, lot # 36140; Catalog number 90254, lot numbers 36009, 36135.