Class 2 Device Recall FlowGate Balloon Guide Catheter;

• Date Initiated by Firm: December 20, 2012
• Date Posted: January 08, 2013
• Recall Status: Terminated on February 05, 2013
• Recall Number: Z-0655-2013
• Recall Event ID: 63938
• 510(K)Number: K122581
• Product Classification: Catheter, percutaneous - Product Code DQY
• 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.
• Code Information: Catalog number 90253, lot # 36140; Catalog number 90254, lot numbers 36009, 36135.
• Recalling Firm/ Manufacturer: Concentric Medical Inc; 301 E Evelyn Ave; Mountain View CA 94041-1530
• For Additional Information Contact: Ruth Kim; 650-810-1742
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: Concentric Medical sent a Urgent Medical Device Recall Notification letter dated December 19, 2012, to all affected customers. The letter identified the product the problme and the action needed to be taken by the customer. Customers were instructed to follow these instructions. 1. Immediately locate the subject devices and quarantine them. 2. Distribute this notice to all affected Departments in your facility. 3. Inform Concentric Medical (Stryker Neurovascular) if any of the subject devices have been distributed to other organizations. a. Please provide contact details so that Concentric Medical (Stryker Neurovascular) can inform those recipients appropriately. 4. Complete and sign the attached Customer Response Form and: Fax it to: 650-237-5230 Please complete this form even if you do not have any subject devices to return to prevent the need of follow up notices. 5. Keep a copy of the completed, signed Customer Response Form for your records. Upon receipt of the returned customer response form, a Stryker Representative will contact you to arrange for credit of returned devices. On behalf of Stryker Neurovascular, we sincerely thank you for your help and support and regret any inconvenience and appreciate your assistance in completing this recall. Should you have any questions concerning this matter please do not hesitate to contact the undersigned.
• Quantity in Commerce: 13 units
• Distribution: US (nationwide) including the states of CA, FL, GA, OR and TN.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DQY and Original Applicant = CONCENTRIC MEDICAL, INC.