Recall Z-2569-2018 ยท DQY Catheter, Percutaneous
Stryker Neurovascular
FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
| Date | Jul 28, 2018 (initiated Apr 11, 2018) |
| Status | Terminated |
| Reason | There may be product manufactured with the outer diameter of the balloon catheter exceeding the defined specification at a customer location. If the user experiences resistance between the FlowGate and an interfacing device, the device would be removed and a second device would be used, which could potentially prolong a procedure. |
| Root cause | Employee error |
| Action | On April 12, 2018, the recalling firm sent Urgent Medical Device Voluntary Customer Communication, Immediate Action Required letters with instructions to return a response form. The letter provided directions for use. |
| Quantity | 968 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153729 | 8F FlowGate2 Balloon Guide Catheter Concentric Medical, Jan 27, 2016 |