FDA-Device2018-08-08Class II
FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
Stryker Neurovascular
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.
Sold states
Nationwide
Affected count
968 units
Manufactured in
47900 Bayside Pkwy, N/A, Fremont, CA, United States
Products
FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2569-2018Don't want to check this manually?
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