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Terminated

Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP 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.

FDA Recall Z-1021-2019 · Posted None

Recalling FirmCook Medical Incorporated
Recall StatusTerminated
Product CodeDTK
Date Initiated2019-02-25
Date Terminated2020-09-29
Product Quantity91731 total

Reason for Recall

Updates to the Instructions for Use.

Firm Action

Cook Medical sent an Urgent Medical Device Correction notification letters dated February 25, 2019 to customers. Additional customers identified later were sent letters on 3/8/19. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return it via fax (812.339.7316) or email ([email protected]). For questions or concerns, contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235.

Root Cause

Labeling Change Control

Distribution Pattern

The products were distributed US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172557Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps · 2017-11-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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