August 29, 2014 — Cook Medical recalled 696 of its CloverSnare four-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.
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 notified all customers 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 [email protected]
For more information: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm410815.htm