FDA Device recall Z-2569-2018
FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
- FDA Device
- Class II
- terminated
- Published 2018-08-08
On 2018-08-08 the FDA classified a Class II recall of FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size) by Stryker Neurovascular, citing 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 be….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2569-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-11 |
| Published | 2018-08-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Neurovascular |
| Distribution | US |
Product
FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
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.
Identifiers
| code_info | Lots 1352, 1630, 1631, 1802, 1970, 2652, 2653, 2654, 2655, 2656, 2657, 2658, 2659, 3169, 3940, 3941 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Stryker Neurovascular
- INZONE DETACHMENT SYSTEM, REF: M00345100950
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FDA Device · Class II · 2024-06-12 · Stryker Neurovascular - The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions
FDA Device · Class II · 2024-06-12 · Stryker Neurovascular - The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions
FDA Device · Class II · 2024-06-12 · Stryker Neurovascular
All Stryker Neurovascular recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2569-2018%22
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