Stryker Neurovascular Recall: FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) a
Stryker Neurovascular Recall: FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) a is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Stryker Neurovascular; Product: FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size); Reason for recall: There may b
| Recalling firm | Stryker Neurovascular |
|---|---|
| Product | FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size) |
| Reason for recall | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide |
| Recall initiated | 20180411 |
| Recall number | Z-2569-2018 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
Try RecallGuard →