Medtronic’s Recently Approved Varicose Vein Device Slapped With Recall

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. T

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