A warning letter was sent to St. Jude Medical Inc. from the U.S. Food and Drug Administration (FDA) regarding its faulty manufacturing practices at its catheter manufacturing plant in Minnetonka, Minnesota. According to BizJournal, the warning letter was released in a regulatory filing with the U.S. Securities and Exchange Commission (SEC).
The FDA had inspected St. Jude Medical’s Atrial Fibrillation (AF) Division’s catheter facility on numerous occasions from December 8 to December 19. On December 19, the FDA notified St. Jude Medical that issues with the manufacture and assembly of its Safire ablation catheter were observed, which are designed to correct irregular heartbeats and destroy damaged and diseased tissue with heat.
St. Jude Medical will not be approved by the FDA to manufacture the new medical devices at its plant until it fixes the cited problems, which included faulty record keeping.
St. Jude Medical has been the center of controversy before when its Symmetry Bypass Aortic Connector was associated with a high occurrence of heart attacks, respiratory failure and several deaths. Adverse side affects of the device included graft narrowing, valve leakage, failed deployment and occlusion.
The Symmetry Bypass Aortic Connector had been approved in 2001 after a shortened approval process. Thousands of these devices have been implanted in patients. Even though there have been reports of adverse side effects, St. Jude Medical has not done anything to alter the design.