FDAFDA · Food and drugs·Recall number Z-2569-2018
FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
Published August 8, 2018 · Recall initiated: April 11, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Neurovascular
- Distributor
- Nationwide
- Lot
- Lots 1352, 1630, 1631, 1802, 1970, 2652, 2653, 2654, 2655, 2656, 2657, 2658, 2659, 3169, 3940, 3941
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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