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U.S. Department of Health and Human Services

Class 2 Device Recall Concentric 7F Balloon Guide Catheter

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  Class 2 Device Recall Concentric 7F Balloon Guide Catheter see related information
Date Initiated by Firm February 27, 2009
Date Posted January 12, 2011
Recall Status1 Terminated 3 on January 13, 2011
Recall Number Z-0899-2011
Recall Event ID 51401
510(K)Number K021899  
Product Classification Catheter, ventricular, general &, pastic surgery - Product Code GBS
Product Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA
Product is 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. Not intended for use to deliver embolic agents or to perform angioplasty.
Code Information Lot numbers 33367 and 33407
Recalling Firm/
Manufacturer		 Concentric Medical Inc
301 E Evelyn Ave
Mountain View CA 94041-1530
For Additional Information Contact
650-810-1716 Ext. 1707
Manufacturer Reason
for Recall		 Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Concentric Medical products sent an URGENT VOLUNTARY MEDICAL DEVICE REMOVAL letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and identify any affected product. Quarantine the product and call Concentric Medical Customer Service at 877-471-0076 (USA toll-free) or 650-938-2100 to receive instructions for returning the devices. For questions regarding this recall call 877-471-0076.
Quantity in Commerce 36 units affected.
Distribution Worldwide Distribution - USA including AL, FL, GA, IL, MN, NY, OH, OR, PA, TX, VA, WA, and WV and one consignee in Turkey and one in Switzerland
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 = GBS and Original Applicant = CONCENTRIC MEDICAL, INC.
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