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.
- Company
- Concentric Medical Inc
- Recall Initiated
- February 27, 2009
- Posted
- January 12, 2011
- Terminated
- January 13, 2011
- Recall Number
- Z-0899-2011
- Quantity
- 36 units affected.
- Firm Location
- Mountain View, CA
Reason for Recall
Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing.
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
Lot / Code Info
Lot numbers 33367 and 33407
Root Cause
Nonconforming Material/Component
Action Taken
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.