Cook Medical recalled 696 of its CloverSnare 4-Loop Vascular Retrieval Snare devices. The device, model number VRS-6.0-9.0, 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 CloverSnare consists of four “loops” made of metal wires that are packaged in a sheath. The device is intended for use in the cardiovascular system to manipulate and retrieve foreign objects, such as wire guides, coils, balloons, catheters, and filters.
The problem is that the loop-snare can separate from the shaft. When this happens, the device will not function. The problem can also potentially cause embolization of snare fragments. When this happens, patients may need medical intervention or additional surgery to retrieve fragments.
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.
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.
See the Recall
See also Medical Law Perspectives, December 2013 Report: Thicker Than Water: Liability When Blood Clots Cause Injury or Death
See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues