FlowGate2 Balloon Guide Catheter — Class II medical device recall Z-2569-2018
Terminated recall by Stryker Neurovascular, reported 2018-08-08, distributed nationwide. There may be product manufactured with the outer diameter of the balloon catheter exceeding the defined specif
| Recall number | Z-2569-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Neurovascular, Fremont, CA, United States |
| Recall initiated | 2018-04-11 |
| Classified | 2018-07-28 |
| Reported by FDA | 2018-08-08 |
| Terminated | 2021-04-28 |
| Distributed | Nationwide (US) |
| Quantity | 968 units |
| Lot numbers | 1352, 1630, 1631, 1802, 1970, 2652, 2653, 2654, 2655, 2656, 2657, 2658, 2659, 3169, 3940, 3941 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2569-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.