FDA sends warning letter to St. Jude Medical regarding issues at Atlanta facility

Tim Casey | | Cardiovascular Business | Heart Failure

The FDA sent a warning letter to St. Jude Medical regarding a facility in Atlanta where the company manufactures its CardioMEMS heart failure system. St. Jude Medical revealed the information in an 8-K filing to the Securities and Exchange Commission on Oct. 1.

The FDA said St. Jude Medical did not conform with current good manufacturing practice at its Atlanta facility. The letter did not mention any other facility and did not identify concerns regarding the performance of the CardioMEMS system or any other St. Jude Medical product.

In May 2014, the FDA approved the CardioMEMS system, which is the first permanently implantable wireless system intended to measure pulmonary artery pressures in patients with heart failure. The FDA had rejected the device's approval application in 2011.

After St. Jude Medical received a form from the FDA on July 6, the company wrote to the agency and detailed its corrective actions. The FDA inspected the Atlanta facility from June 8 to June 26.

“Since the completion of the FDA inspection, the Company has provided and will continue to provide the FDA with regular monthly updates, and the FDA warning letter acknowledges the actions already taken by the Company to address the observations,” St. Jude Medical said. “The Company is in the process of working diligently to completely remediate the FDA’s observations for the Atlanta facility and fully integrate this former CardioMEMS stand-alone facility into St. Jude Medical’s quality systems.”

Tim Casey,

Executive Editor

Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.

Related Content

How private equity influences care for heart failure patients
FDA sees promise in new total artificial heart technology, granting it ‘breakthrough’ status
FDA wants new heart damage warnings added to COVID-19 vaccines
2 out of 5 heart failure patients are not seeing a cardiologist
Duke specialists to detail the benefits of treating heart failure with Barostim
New drug for obstructive HCM outperforms the current standard of care

Around the web

Health Exec
Tom Price: Medical residency slots need to expand to combat physician shortages

Tom Price, MD, former secretary of Health and Human Services (HHS), said one way to address the growing shortage of physicians is to expand medical resident positions, but these are tied to Medicare spending so alternative means may be needed.

Health Imaging
Tariffs will have a significant impact on the nuclear imaging supply chain in the US

"Domestic radiopharmaceutical suppliers, who receive isotopes from abroad, would be impacted by price changes and uncertainty caused by additional tariffs,” SNMMI President Cathy Cutler, PhD, wrote in a letter to the U.S. Department of Commerce this week.

Radiology Business
U.S. iodine contrast supply may not be subject to proposed 25% tariffs

If President Trump initiates a 25% tariff against pharmaceuticals imported from Ireland, it might impact the price for X-ray iodine contrast agents in the U.S. depending what rules are put in place.