Z-2569-2018 Class II Terminated
FDA device recall Z-2569-2018 was initiated by Stryker Neurovascular on Apr 11, 2018 and is designated Class II. 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… The recall status is terminated (terminated Apr 28, 2021). Affected quantity: 968 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 8, 2018
- Initiation Date
- Apr 11, 2018
- Termination Date
- Apr 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 968 units
Product Description
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.
Distribution Pattern
Nationwide
Code Information
Lots 1352, 1630, 1631, 1802, 1970, 2652, 2653, 2654, 2655, 2656, 2657, 2658, 2659, 3169, 3940, 3941
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2569-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026