According to FDA, St. Jude Medical has violated the Federal Food, Drug, and Cosmetic Act with marketing claims for its Epicor surgical ablation devices. The agency says that St. Jude is marketing the devices to treat atrial fibrillation, a common heart-rhythm disorder, without federal approval.

Some surgeons use ablation devices to treat atrial fibrillation by burning really small amounts of heart tissue. However, none of the manufacturers have FDA approval to market the devices for this use. St. Jude says that Epicor is "designed to safely, effectively, and reproducibly create a classic box lesion in a single step." In other words, atrial fibrillation treatment is not spelled out, but the terms in the statement refer to a burn pattern that surgeons create when using the devices for this unapproved use.

A St. Jude spokeswoman said that the company "is working diligently to address the points raised in the warning letter and to resolve the FDA's concerns."