Recall Z-0655-2013 ยท DQY Catheter, Percutaneous
Concentric Medical Inc
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&a
| Date | Jan 8, 2013 (initiated Dec 20, 2012) |
| Status | Terminated |
| Reason | Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration. |
| Root 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 Concentri |
| Quantity | 13 units |
| Distribution | US (nationwide) including the states of CA, FL, GA, OR and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122581 | MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254 Concentric Medical, Inc., Nov 21, 2012 |