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

Recall date

April 11, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2569-2018

FDA classification

Class II

Brand / firm

Stryker Neurovascular

Sold / distributed

Nationwide

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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