St. Jude Medical Gets FDA Warning Letter On Atrial Fibrillation Plant

St. Jude Medical Inc. has received a warning letter from the U.S. Food and Drug Administration (FDA) regarding issues at a Minnesota facility where the company manufactures products to fix a common heart-rhythm disorder called atrial fibrillation.

The letter involves manufacturing issues the FDA discovered that are related to a version of the company’s Safire ablation catheter, which is used to carefully burn heart tissue to disengage electrical signals that cause atrial fibrillation.

Atrial fibrillation made up nearly 13 percent of the St. Paul, Minn.-based company’s $4.36 billion in sales last year.

To see the complete warning letter, go to www.fda.gov/foi/warning_letters/ s7169c.htm.

St. Jude Medical did not immediately return calls seeking comment.