St. Jude Safire Ablation Catheter Plant is Subject of FDA Warning

The Minnesota manufacturing plant where the St. Jude Safire ablation catheter is made was the subject of a recent warning letter issued by the FDA about non-conforming manufacturing practices.

According to a disclosure filed with the Securities and Exchange Commission, the FDA inspected St. Jude Medical’s Atrial Fibrillation (AF) Division catheter plant in Minnetonka, Minnesota between December 8, 2009 and December 19, 2008, and identified problems related to the manufacturing and assembly of the Safire ablation catheter.

Ablation catheters are surgical devices that are used to treat atrial fibrillation by cauterizing, or searing, the heart tissue that sends irregular or electrical signals to the heart’s upper chambers. If left untreated, atrial fibrillation can increase the risk of a stroke. The devices are also used to destroy dead and damaged tissue.

The FDA warning to St. Jude was issued April 17, 2009, and indicates that the regulatory agency will not approve any new devices to be manufactured at the facility until the company address the manufacturing practices.

According St. Jude’s CEO, Dan Starks, the warning was related to a documentation issue, which they are already working to resolve.

Manufacturers of medical devices and pharmaceutical products can receive FDA warning letters when they are found to not be following good manufacturing practices or marketing regulations. In many cases, the warning letters can take a substantial amount of time and cost to resolve.

St. Jude indicates that they had no plans to seek approval for any new devices that would be manufactured at the Minnesota facility and suggested that the issue would not have much impact on sales or their ability to fill customers’ orders.