medical Class II Updated 2018-08-08

Stryker Neurovascular recalls FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) a

Recalled Product

FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lots 1352, 1630, 1631, 1802, 1970, 2652, 2653, 2654, 2655, 2656, 2657, 2658, 2659, 3169, 3940, 3941
View official government recall

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