Posted by Marilyn McGoldrick on May 2, 2013 1:30:00 PM

The FDA has issued a Class I recall of dialysis concentrates GranuFlo and NaturaLyte because the products could put patients at risk for heart attacks and other serious cardiovascular problems. These products would have been administered to dialysis patients being seen in facilities run by or supplied by Fresenius Medical Care North America, the manufacturer of GranuFlo & NaturaLyte.

Fresenius Medical Care North America is based in Massachusetts and is the largest operator of hemodialysis clinics in the U.S. as well as the leading supplier of dialysis machines and disposable products and supplies. Fresenius has its own dialysis centers with its name on the door, but also supplies products to other dialysis centers. As a dialysis patient, you are often not aware of the specific names of the products being used, so you may not even realize your treatments have involved GranuFlo and NaturaLyte. It is estimated that Fresenius Medical Care treats approximately 1/3 of the nation’s 390,000 dialysis patients.

The Food and Drug Administration (FDA) began an investigation of Fresenius’s GranuFLo and NaturaLyte products in 2012. The FDA investigation came about because investigators learned of an internal Fresenius memo that reported a significant increase in the risk of heart attacks in patients using GranuFlo. Although Fresenius issued this warning memo internally in November of 2011, it apparently did nothing to warn doctors and dialysis centers that used the Fresenius products in centers not operated by Fresenius. From November of 2011 through March of 2012, Fresenius may have allowed the use of its products knowing that use could lead to heart attack or death in patients. It has been estimated that as many as 125,000 dialysis patients in the U.S. use Fresenius products in facilities not owned by Fresenius. Fresenius took no steps to warn non-Fresenius clinics or patients at those clinics, despite knowing that 941 patients treated at Fresenius clinics suffered heart attacks in 2010 alone.

The risks associated with the use of GranuFlo and NaturaLyte include:

  • Sudden cardiac arrest
  • Sudden heart attack
  • Hemodialysis cardiac arrest
  • Hemodialysis cardiopulmonary arrest
  • Stroke
  • Death
  • Arrhythmia
  • Altered mental status (confusion)
  • Low blood pressure

If you or a loved one has suffered cardiac arrest or any other cardiac injury while undergoing dialysis, please contact GranuFlo and NaturaLyte Attorney Marilyn McGoldrick of Thornton Law Firm in Boston, Massachusetts for a free consultation to investigate if your injury is related to GranuFlo and NaturaLyte. Our toll-free number is 1-888-341-1405.


New York Times article: Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry

The Fresenius Internal Memo