Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918

IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events

Cook issued Urgent Medical Device Correction letter on February 14, 2022 via courier to US consignees. Letter states reason for recall, health risk and action to take: 1. Please read the new IFU in entirety. 2. The electronic versions of the IFUs can be found on the Cook Medical website by Catalogue Number (RPN): https://ifu.cookmedical.com/ifuPub/searchIfu.jsf 3. Your Cook Medical Sales Representative can facilitate delivery of new IFUs for your inventory upon request. 4. Please complete and return the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email ([email protected]). 5. Please continue to report any adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time) or by email to [email protected]. 6. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA. Visit http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm to obtain a form to fax or mail or call the FDA at 800.FDA.1088. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices may have been transferred. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235