Class 2 Device Recall FlowGate2 Balloon Guide Catheter

• Date Initiated by Firm: April 11, 2018
• Date Posted: July 28, 2018
• Recall Status: Terminated on April 28, 2021
• Recall Number: Z-2569-2018
• Recall Event ID: 80353
• 510(K)Number: K153729
• Product Classification: Catheter, percutaneous - Product Code DQY
• Product: FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
• Code Information: Lots 1352, 1630, 1631, 1802, 1970, 2652, 2653, 2654, 2655, 2656, 2657, 2658, 2659, 3169, 3940, 3941
• Recalling Firm/ Manufacturer: Stryker Neurovascular; 47900 Bayside Pkwy; Fremont CA 94538-6515
• For Additional Information Contact: Angelica Beckmann; 510-413-2900
• Manufacturer 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.
• FDA Determined Cause: Employee error
• Action: On April 12, 2018, the recalling firm sent Urgent Medical Device Voluntary Customer Communication, Immediate Action Required letters with instructions to return a response form. The letter provided directions for use.
• Quantity in Commerce: 968 units
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DQY