UPDATED 09/04/2014. Classified as Class I Recall. See Complete Listing of Affected Lot Numbers
AUDIENCE: Risk Manager, Surgery, Radiology
ISSUE: Cook Medical recalled 696 of its CloverSnare 4-Loop Vascular Retrieval Snare devices, model Number VRS-6.0-9.0. 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.
The recall affects products manufactured between August 2012 and August 2013 and distributed between March 8, 2013 and July 1, 2014. The recall affects customers in the United States, Canada, Austria, Belgium, Denmark, Germany, Great Britain, Ireland, Italy, Spain, Sweden and Switzerland.
BACKGROUND: 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.
RECOMMENDATION: Cook Medical notified all customers on July 10 2014 of the recall by letter and has arranged for affected devices to be returned. Customers with questions may contact Cook Medical at 800-457-4500 or by email at CustomerrelationsNA@cookmedical.com