FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size)… recallZ-2569-2018 · Stryker Neurovascular · initiated Apr 11, 2018
Class II Terminated All recalls posted in July 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Neurovascular or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-2569-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 11, 2018
- Posted by the FDA
- Jul 28, 2018
- Recalling firm
- Stryker Neurovascular
- Quantity
- 968 units
- Product code
- DQY
- FDA submissions
- K153729
- Distribution
- Nationwide
Product description
FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
Code information (models, lots, serial numbers)
Lots 1352, 1630, 1631, 1802, 1970, 2652, 2653, 2654, 2655, 2656, 2657, 2658, 2659, 3169, 3940, 3941
Other devices under the same FDA submission
2 devices cleared under K153729 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- FlowGate2 90495Stryker Corporation · CATHETER, PERCUTANEOUS1 recall94 reports
- FlowGate2 90485Stryker Corporation · CATHETER, PERCUTANEOUS1 recall63 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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