Reported Jan 16, 2013 · Terminated

FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA.…

Concentric Medical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Concentric Medical Inc · 301 E Evelyn Ave · Mountain View, CA · 94041-1530

FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate&amp;amp;amp;amp;amp;amp;amp;amp;quot; 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&amp;amp;amp;amp;amp;amp;amp;amp;quot; 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.

Lot codes and dates: Catalog number 90253
lot # 36140
Catalog number 90254
lot numbers 36009
36135
Amount recalled: 13 units

Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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