CloverSnare 4-Loop Vascular Retrieval Snare by Cook Medical Recalled due to Risk of Loop to Separate From Shaft
Risk Managers, Surgery, and Radiology healthcare personnel are informed by the FDA 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 Alert on CloverSnare 4-Loop Vascular Retrieval Snare
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.
So far, they 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 thru August 2013 and they were distributed from March 8, 2013 to July 1, 2014.
FDA Recommendation on CloverSnare 4-Loop Vascular Retrieval Snare
“Cook Medical notified all customers on July 10 2014 of the recall by letter and has arranged for affected devices to be returned. Customers with questions may contact Cook Medical at 800-457-4500 or by email at CustomerrelationsNA@cookmedical.com”
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