Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2569-2018 — FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)

U.S. FDA — Device Enforcement · United States · 2018-04-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2569-2018
Date of alert
2018-04-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Neurovascular
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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