FDAFDA · Food and drugs·Recall number Z-0655-2013
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.
Published January 16, 2013 · Recall initiated: December 20, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Concentric Medical Inc
- Distributor
- US (nationwide) including the states of CA, FL, GA, OR and TN.
- Lot
- Catalog number 90253, lot # 36140; Catalog number 90254, lot numbers 36009, 36135.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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