Cook Medical Tulip Vena Cava Filter Set Recall: Updated Instructions for Use

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Recalling firmCook Medical Incorporated400 N Daniels Way, N/A · Bloomington, IN 47404-9155

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Cook Medical is recalling Tulip Vena Cava Filter Sets for femoral and jugular vein approaches because their Instructions for Use have been updated. This recall does not involve a safety hazard but requires users to follow the latest instructions to ensure proper medical use.

Why it’s dangerous

The recall is due to updated Instructions for Use, meaning older versions might not align with current medical practices. This could lead to improper use if the instructions are not followed correctly.

Who’s affected

Patients undergoing procedures to prevent pulmonary embolism may be affected. Medical professionals using these filters for vein approaches are most at risk if they continue using outdated instructions.

How to tell if you have this one

Check the product's catalog number (IGTCFS-65-1-UNl-TULIP) and lot numbers listed from E3401464 to E3817898. The product is used for preventing pulmonary embolism via vena cava placement.

Brand
Cook Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Review Updated Instructions
Check the latest Instructions for Use provided by Cook Medical to ensure proper application for preventing pulmonary embolism.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

Cook Medical updated the Instructions for Use for these filters to align with current medical practices.

Do I need to stop using this product?

No, but you must follow the updated Instructions for Use to ensure safe medical application.

What lot numbers are affected?

Affected lots range from E3401464 to E3817898 as listed in the recall notice.

Take action

Contact Cook Medical

We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1023-2019 — Cook Medical Cook Medical

Hello,

I own a Cook Medical that is covered by recall Z-1023-2019 from Cook Medical.

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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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-1023-2019 (February 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1023-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.

Cook Medical Incorporated recalls Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP Product

Lower-risk recall