Recall Z-0899-2011 ยท GBS Catheter, Ventricular, General & Plastic Surgery
Concentric Medical Inc
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
| Date | Jan 12, 2011 (initiated Feb 27, 2009) |
| Status | Terminated |
| Reason | Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing. |
| Root cause | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021899 | CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 Concentric Medical, Inc., Jul 10, 2002 |