Federal regulators have found problems with St. Jude Medical's documentation of quality checks for a product used to treat heart disease.
St. Jude, based in St. Paul, says FDA inspectors determined the company was not properly recording quality control procedures related to the manufacture of an ablation catheter.
The company says the FDA did not find any problems with the safety or efficiency of the device.
An ablation catheter is a long, thin, flexible tube. It's guided through a blood vessel to a patient's heart. Energy is sent through the tube to destroy small areas of heart tissue that may cause irregular heartbeats to start.
St. Jude says customer orders are not expected to be affected while it works to resolve FDA record-keeping concerns.
In 2008, the ablation catheter had total sales of about $6 million. St. Jude says it believes it can resolve the FDA's concerns without a significant hit to profits.