On July 10, 2014, Cook Medical initiated a recall of 696 of its CloverSnare™ 4-Loop Vascular Retrieval Snare devices because of a potential for the loop to separate from the shaft. In this event there would be a loss of device function, potential for embolization of snare fragments and the potential need for intervention to retrieve the separated snare.
The model involved is the CloverSnare™ 4-Loop Vascular Retrieval Snare, reference VRS-6.0-9.0. 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.
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.
Cook Medical has notified all customers of the recall by letter and has arranged for affected devices to be returned. In addition, the company 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.
Source: Cook Medical