There have been six customer reports of separation of the loop snare from the shaft during use.
San Diego, CA (PRWEB) August 25, 2014
AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on CloverSnare 4-Loop Vascular Retrieval Snare devices.
The US FDA announced on August 20, that 696 CloverSnare 4-Loop Vascular Retrieval Snare devices, model Number VRS-6.0-9.0, by Cook Medical, are recalled due to risk of loop to separate from shaft.
FDA’s reason for the recall is based on the potential for the loop to separate from the shaft, that can lead to loss of device function, and may cause embolization and the need for retrieval intervention.
There have been six customer reports of separation of the loop snare from the shaft during use. The recall affects devices in the following countries: United States, Canada, Switzerland, Sweden, Spain, Italy, Ireland, Great Britain, Germany, Denmark, Belgium, and Austria. The affected devices were manufactured from August 2012 through August 2013 and they were distributed from March 8, 2013 to July 1, 2014.
Taking into consideration the latest developments, AttorneyOne.com monitor daily and update the website providing accurate information on all relevant FDA safety alerts. Sean Burke, director of Media Relations at AttorneyOne.com, adds, “We are determined to keep an eye on FDA announcements concerning CloverSnare 4-Loop Vascular Retrieval Snare devices and inform the public. For that reason," he continues, "our focus should squarely fall on investigating these safety alerts and getting the word out.”
According to the announcement “Cook Medical notified all customers on July 10, 2014 of the recall by letter and has arranged for affected devices to be returned.”
AttorneyOne.com has further information on CloverSnare 4-Loop Vascular Retrieval Snare devices at the website including the latest major drug, medical products, and food law news.
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