Cook Medical Incorporated recalls Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP Product Usage: The G…

Recall date

February 25, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1022-2019

FDA classification

Class III

Brand / firm

Cook Medical Incorporated

Sold / distributed

The products were distributed US Nationwide Distribution

Why it was recalled

Updates to the Instructions for Use.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP Product Usage: The Gunther Tulip Filter implant 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.