Medtronic Hit with Recall over Recently Approved Varicose Vein Device

The VenaSeal system received a PMA in February.

Chris Newmarker

Medtronic is recalling 1661 units of its VenaSeal varicose vein closure system, only about three months after it received a PMA.

The recall, which the FDA recently designated as Class II, involves units sold outside of the United States, including in Australia, Canada, France, Germany, Hong Kong, Ireland, Italy, Latvia, Netherlands, Norway, Portugal, Switzerland, UAE, and the United Kingdom.

The issue involves a possible sterility breach of the outer packaging (pouch) material. The FDA says such breach might compromise the outside surface sterility of the sealed inner tray.

There are temporary or medically reversible adverse health consequences involved, though the recall is not as bad as a Class I.

Medtronic (Dublin, Ireland) sent out a recall notification via letter and email on April 28. Mansfield, MA was listed as the manufacturer's address.

The technology was actually developed by Sapheon Inc. (Morrisville, NC), which Covidien acquired last year. Medtronic then acquired Covidien in a $48 billion deal that closed in January.

The VenaSeal system is meant to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent, a specially formulated n-butyl-2-cyanoacrylate.

"This new system is the first to permanently treat varicose veins by sealing them with an adhesive, thereby giving patients another treatment option for this common condition," William Maisel, MD, chief scientist at FDA's Center for Devices and Radiological Health, said at the time of the PMA.

"Because the VenaSeal system does not incorporate heat application or cutting, the in-office procedure can allow patients to quickly return to their normal activities, with less bruising," Maisel said.

Medtronic planned to launch VenaSeal in the U.S. this spring.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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