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U.S. Department of Health and Human Services

Enforcement Report - Week of January 16, 2013
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Event Detail

Event ID 63938
Product Type Devices
Status Ongoing
Recalling Firm Concentric Medical Inc
City Mountain View
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-20
Initial Firm Notification of
Consignee or Public		 Letter
Distribution Pattern US (nationwide) including the states of CA, FL, GA, OR and TN.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Catalog number 90253, lot # 36140; Catalog number 90254, lot numbers 36009, 36135. Class II Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration. 13 units Z-0655-2013
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