Z-2569-2018Class II

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

Name: Z-2569-2018 FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
Creator: Stryker Neurovascular
Published: 2018-04-11
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2018-04-11 / Terminated / root cause: manufacturing process

FDA source

Stryker Neurovascular began a recall of FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size) on 2018-04-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2569-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-11
Posted: 2018-07-28
Terminated: 2021-04-28
Recalling firm: Stryker Corp.
Product: FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
Product code: DQY Catheter, Percutaneous
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.
Root cause tag: manufacturing process
FDA root 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
Product codes and lots: Lots 1352, 1630, 1631, 1802, 1970, 2652, 2653, 2654, 2655, 2656, 2657, 2658, 2659, 3169, 3940, 3941

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2569-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2569-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28

Product code DQY

K153729Class II8F FlowGate2 Balloon Guide CatheterConcentric Medical / cleared 2016-01-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)