Stryker recalls FlowGate2 Balloon Guide Catheters with specific sizes due to potential balloon size issues that may prolong procedures during medical use.
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.
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.
The catheter's balloon may be too large in some units, causing resistance when it meets other medical devices. If this happens, the procedure might need to switch to a second device, which could extend the surgery time.
Medical professionals using these catheters during procedures are most at risk. Patients undergoing surgery with these specific catheters could experience longer procedures due to potential resistance issues.
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.
Look for the lot numbers listed: 1352, 1630, 1631, 1802, 1970, 2652, 2653, 2654, 2655, 2656, 2657, 2658, 2659, 3169, 3940, 3941.
Confirm the model is either 90485 (8Fx85cm) or 90495 (8Fx95cm) to ensure it's part of the recall.
The catheter may have a balloon size exceeding specifications, which could cause resistance during use and require switching to a second device, potentially prolonging the procedure.
Check the product lot number and model size to see if it's part of the recall. If it is, contact Stryker for guidance.
The recall addresses potential procedure prolongation, not direct injury risks. The official notice does not mention injury.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2569-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2569-2018 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
