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Concentric Medical Inc recalls FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate&amp
Recalled January 16, 2013 · FDA recall Z-0655-2013 · Concentric Medical
Hazard
Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration. · FDA Class II
Units
13 units
Sold at
US (nationwide) including the states of CA, FL, GA, OR and TN.
Description
Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration.
Product
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.
Manufacturer(s)
Concentric Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →