The FDA issued a warning this month on Cook Medical’s medical device recall, warning that a defect in certain of the company’s CloverSnare 4-Loop Vascular Retrieval Snares could harm patients.

Federal device regulators gave the recall Class I status, reserved for "situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."

Cook recalled nearly 700 units of the CloverSnare 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.

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.