Choose your Region

Are you sure you want to proceed?

You will be leaving the Cook Medical website that you were viewing and going to a Cook Medical website for another region or country. Not all products are approved in all regulatory jurisdictions. The product information on these websites is intended only for licensed physicians and healthcare professionals.

Search Cook Medical

Newsroom
August 19th, 2014

CloverSnare™ 4-Loop Vascular Retrieval Snare Recall


For Immediate Release: August 26, 2014

Cook Medical

750 Daniels Way

Bloomington, IN 47404

www.cookmedical.com

Telephone Number:  812-339-2235

On July 10, 2014, Cook Medical initiated a recall of 696 of its CloverSnare™ 4-Loop Vascular Retrieval Snare devices. The device was recalled because of a potential for the loop to separate from the shaft, resulting in loss of device function, potential for embolization of snare fragments and the potential need for intervention to retrieve the separated snare.

Customers have been advised to return the recalled devices to Cook Medical. The recall affects products manufactured between August 2012 and August 2013 and distributed between March 8, 2013, and July 1, 2014.

The following product has been recalled:

Model: CloverSnare™ 4-Loop Vascular Retrieval Snare

Model Number: VRS-6.0-9.0

Lot Numbers: 3583416; 3583418; 3583422; 3583424; 3583426; 3583428; 3583430; 3583432; 3583434; 3583436; 3583440; 3583442; 3583452; 3583456; 3583458; 3583462; 3583464; 3583466; 3583468; 3583470; 3583472; 3583474; 3583476; 3583478; 3583480; 3583482; 3583484; 3583486; 3583488; 3583490; 3583492; 3583494; 3583496; 3583498; 3583500; 3583502; 3583504; 4293921; 4293923; 4293925; 4293927; 4319573; 4319575; 4319577; 4319579; 4319581; 4319583; 4319585; 4319587; 4319589; 4319591; 4572365; 3583418X; 3583430X; 3583442X; 3583442XX; 3583464XXX; 3583480XX; 3583486X

Quantity: 696

In six cases, customers reported separation of the loop snare from the shaft during use. The separation was caused by the application of lateral force to the snare in an effort to change the shape of the device. In four cases of separation, medical intervention to retrieve the separated snare was required.

Cook Medical has notified all customers of the recall by letter and has arranged for affected devices to be returned. In addition, Cook Medical has notified the FDA of this action. The recall affects customers in the United States, Canada, Austria, Belgium, Denmark, Germany, Great Britain, Ireland, Italy, Spain, Sweden and Switzerland. Cook reports that the problem occurred only in these specific lots. There have been no known problems in the devices manufactured after that time.

Customers with questions may contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235 Monday through Friday between 7:30 a.m. and 5:00 p.m. Eastern Daylight Time or by email at CustomerrelationsNA@cookmedical.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

About Cook Medical
Since 1963 Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we are combining medical devices, biologic materials and cellular therapies to help the world’s healthcare systems deliver better outcomes more efficiently. We have always remained family owned so that we have the freedom to focus on what we care about: patients, our employees and our communities. Find out more at www.cookmedical.com, and for the latest news, follow us on TwitterFacebook and LinkedIn.