Cook Medical announced this week that it recalled nearly 700 units of its CloverSnare 4-Loop Vascular Retrieval Snare devices after receiving complaints that the devices came apart during use.
Cook said that at least 6 customers complained that the loop snare separated from the shaft during use and 4 of those instances required medical intervention to get the snare back. The issue also causes the device to cease functioning and puts patients at risk of embolization, Cook said.
The device maker issued a warning to its other customers and asked that they return affected lots, adding that there have been no reported issues associated with product manufactured after August 2013.
The recall affects 696 total CloverSnare devices with model number VRS-6.0-9.0, which were distributed between March 8, 2013, and July 1, 2014. The devices were distributed in the U.S., Canada, Austria, Belgium, Denmark, Germany, Great Britain, Ireland, Italy, Spain, Sweden and Switzerland, according to the Cook warning.