Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach Recalled by Cook Medical Incorporated Due to Updates to the Instructions for Use.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cook Medical Incorporated directly.
Affected Products
Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP Product Usage: The Gunther Tulip Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:(1) Pulmonary thromboembolism when anticoagulant therapy is contraindicated; (2) Failure of anticoagulant therapy in thromboembolic diseases; (3) Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and (4) Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Filter implant may be retrieved if clinically indicated. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.
Quantity: 91731 total
Why Was This Recalled?
Updates to the Instructions for Use.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cook Medical Incorporated
Cook Medical Incorporated has 53 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report