Concentric Medical Inc: Medical Device Recall in 2013 - (Recall #: Z-0655-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 20, 2012

Date Posted: January 16, 2013

Recall Number: Z-0655-2013

Event ID: 63938

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.

Status: Terminated

Product Quantity: 13 units

Code Information:

Catalog number 90253, lot # 36140; Catalog number 90254, lot numbers 36009, 36135.

Distribution Pattern:

US (nationwide) including the states of CA, FL, GA, OR and TN.

Voluntary or Mandated:

Voluntary: Firm initiated