A novel way to seal varicose veins is being recalled less than three months after the PMA was approved.
The FDA approved the marketing of Medtronic’s VenaSeal closure system on Feb. 20. However, on May 12 the agency announced the Class II recall of 1,661 units of the device distributed worldwide. According to the announcement, the devices are being recalled because of a possible sterility breach in the outer packaging material. None had made it to U.S. shelves; instead, the kits had been sold in Australia, Canada, Europe, Hong Kong and the UAE.
Medtronic contacted purchasers of the kits by email on April 28. According to the company, the recall is not being triggered by a regulatory agency or field complaint. Instead, it discovered the possibility of a sterility breach during standard internal package testing. Medtronic is asking owners of unused kits to return them as part of the recall.
The VenaSeal system is used in patients with superficial but symptomatic varicose veins of the legs. It is made up of an adhesive and delivery system components including a catheter, guidewire, dispenser gun, dispenser tips and syringes. It was the first varicose vein closure system to use an adhesive. Previous treatment methods used drugs, lasers, radio waves or surgery. The PMA was filed by Covidien, which has since merged with Medtronic.
View the recall announcement at www.fdanews.com/05-25-15-venaseal.pdf. — Elizabeth Orr