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Terminated

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

FDA Recall Z-2569-2018 · Posted 2018-07-28

Recalling FirmStryker Neurovascular
Recall StatusTerminated
Product CodeDQY
Date Initiated2018-04-11
Date Terminated2021-04-28
Product Quantity968 units

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.

Firm 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.

Root Cause

Employee error

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K1537298F FlowGate2 Balloon Guide CatheterConcentric Medical · 2016-01-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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