Stryker Neurovascular: Medical Device Recall in 2018 - (Recall #: Z-2569-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 11, 2018

Date Posted: August 8, 2018

Recall Number: Z-2569-2018

Event ID: 80353

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.

Status: Terminated

Product Quantity: 968 units

Code Information:

Lots 1352, 1630, 1631, 1802, 1970, 2652, 2653, 2654, 2655, 2656, 2657, 2658, 2659, 3169, 3940, 3941

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated