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.
FDA Recall Z-0899-2011 · Posted 2011-01-12
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Recalling FirmConcentric Medical Inc
Recall StatusTerminated
Product CodeGBS
Date Initiated2009-02-27
Date Terminated2011-01-13
Product Quantity36 units affected.
Reason for Recall
Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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