Use caution Medical device recall · FDA · Published April 11, 2018

Stryker FlowGate2 Catheter Recall: Balloon Size Risk

Stryker recalls FlowGate2 Balloon Guide Catheters with specific sizes due to potential balloon size issues that may prolong procedures during medical use.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2569-2018Medical device Stryker ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmStryker Neurovascular47900 Bayside Pkwy · Fremont, CA 94538-6515

✎ GovInfoNow plain-language explainer

Stryker is recalling certain FlowGate2 Balloon Guide Catheters that may have a balloon size exceeding specifications. This could cause procedures to last longer if resistance is felt during use, which is a concern for medical staff performing surgeries. Read more at govinfonow.com/recall/71403-stryker-flowgate2-catheter-recall-balloon-size-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/71403-stryker-flowgate2-catheter-recall-balloon-size-risk · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2569-2018

Cite this page

“Stryker FlowGate2 Catheter Recall: Balloon Size Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71403-stryker-flowgate2-catheter-recall-balloon-size-risk. Based on FDA recall #Z-2569-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2569-2018%22&limit=1).

The FDA announced on April 11, 2018, that Stryker Neurovascular is recalling FlowGate2 Balloon Guide Catheters due to potential outer diameter defects. The agency said the issue could prolong procedures if users experience resistance during use.

How to tell if you have it

Brand: Stryker
Product: FlowGate2 Balloon Guide Catheter
UPN 90485 (8Fx85cm size)
UPN 90495 (8Fx95cm size)
Lots: 1352, 1630, 1631, 1802, 1970, 2652, 2653, 2654, 2655, 2656, 2657, 2658, 2659, 3169, 3940, 3941
Distribution: Nationwide
Units affected: 968

The hazard

According to the FDA, some units may have an outer diameter exceeding specifications. If users encounter resistance between the device and interfacing equipment, they must remove it and use a second device, which could prolong the procedure.

Context

GovInfoNow's records show Stryker Neurovascular has had 16 other recalls since June 26, 2017. Recent brand recalls include the April 6, 2026 Stryker INZONE Detachment System recall for premature battery drain risk and the Aug. 30, 2024 Trevo Trak 21 Microcatheter recall for OUS IFU distribution errors. Other recent recalls of similar products include the April 2, 2026 Philips Bridge Prep Kit recall for catheter resistance risk and the Dec. 24, 2025 Medline Intubation Tray recall for airway obstruction risk.

How to tell if you have this one

Check for the model numbers 90485 (8Fx85cm) or 90495 (8Fx95cm) on the catheter. These were sold in specific production lots: 1352, 1630, 1631, 1802, 1970, 2652, 2653, 2654, 2655, 2656, 2657, 2658, 2659, 3169, 3940, 3941.

Brand
Stryker
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for the lot numbers listed: 1352, 1630, 1631, 1802, 1970, 2652, 2653, 2654, 2655, 2656, 2657, 2658, 2659, 3169, 3940, 3941.
Verify Model Size
Confirm the model is either 90485 (8Fx85cm) or 90495 (8Fx95cm) to ensure it's part of the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3 years after the firm started it.

Apr 11, 2018Firm started the recall
Jul 28, 2018FDA classified it Class II
Aug 8, 2018Published in FDA’s Enforcement Report
Apr 28, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/71403-stryker-flowgate2-catheter-recall-balloon-size-risk">Stryker FlowGate2 Catheter Recall: Balloon Size Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2569-2018 (April 11, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2569-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.