A recall has been issued for the Cook CloverSnare 4-Loop Vascular Retrieval Snare. There is a potential for the snare loop to separate from the shaft. If this occurs, the snare loop may travel through the vascular system and block blood vessels or become stuck in other organs, such as the heart and lungs. Additional intervention may be necessary to retrieve the separated snare loop from the patient. This failure will also cause the device to stop working. Four injuries have been reported. The use of the affected product may cause serious adverse health consequences, including death. For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm412778.htm |