GranuFlo and NaturaLyte Dialysis linked to Heart Attack
The FDA issued the recall after learning of the severe cardiac risks associated with GranuFlo & NaturaLyte.
GranuFlo & NaturaLyte have been recalled by the FDA. On March 29, 2012, the FDA issued a Class I Recall, which is the most severe sanction the FDA can impose. This sanction is reserved for products that cause “serious adverse health consequences or death.”
Fresenius Medical Care manufactures GranuFlo & NaturaLyte, which have been prescribed to over 200,000 dialysis patients. Fresenius is also the leading supplier of dialysis machines and other products used in dialysis clinics across the United States. For months, Fresenius knew that GranuFlo & NaturaLyte were associated with an increased risk of cardiac arrest and heart attack. However, Fresenius did not inform the FDA, dialysis centers or physicians about the cardiac risks.
In November 2011, Fresenius Medical Care, circulated an internal memo regarding the heart attack risk linked to its product, GranuFlo, and similar product NaturaLyte.
What injuries are caused by GranuFlo and NaturaLyte?
In a memo published by the products’ manufacturer, Fresenius Medical Care, it was noted that 941 patients had suffered cardiac arrest in 667 FMC facilities in 2010 alone. (This does not include the number of patients that may have been injured or died in clinics not owned or operated by FMC.)
GranuFlo & NaturaLyte Facts
- 500,000 Americans require dialysis to treat kidney disease.
- There are over 5700 dialysis centers in the United States.
- 3300 dialysis clinics use GranuFlo & NaturaLyte.
- 260,000 dialysis patients have been prescribed GranuFlo & NaturaLyte.
- 125,000 of those dialysis patients have been prescribed GranuFlo & NaturaLyte in non-Fresenius dialysis clinics.
- 4,655 dialysis patients suffered possible GranuFlo-related cardiac arrests between January 1 and December 31, 2010.
- 194 dialysis patients suffered possible GranuFlo-related cardiac arrests in a non-Fresenius clinic each month they went unwarned.
The below injuries must have occurred within 48 hours of dialysis treatment.
- Cardiovascular resulting in death
- Heart attack
- Other catastrophic cardiovascular injuries
- Cardiopulmonary arrest
- Sudden cardiac death
If you or someone you know sustained an injury due to the use of Granuflo® and or Naturalyte®, you may have a right to compensation. Contact us today for a free confidential case evaluation.