GranuFlo dialysis treatment may increase patients’ risk of heart attack or sudden cardiac death by 6 to 8 times.
FDA Recalls GranuFlo
In light of these dangers, the Food and Drug Administration (FDA) issued a Class I Recall of GranuFlo and similar product, NaturaLyte, both manufactured by Fresenius Medical Care. A Class I recall is the most urgent level of recall and is utilized when there is “reasonable probability that the use of or exposure to the product will cause serious negative health consequences or death.”
GranuFlo Manufacturer Hid Risks
An article in The New York Times alleged that GranuFlo maker Fresenius sent an internal memo in November 2011 discussing the 6 to 8 times increased heart attack risk linked to both dialysis products. Fresenius – the largest producer of dialysis products – did not bother to warn consumers, doctors or the FDA of these risks. In fact, the FDA was unaware of GranuFlo’s dangers until the Fresenius document was anonymously leaked to the Agency.
After conducting an investigation into GrauFlo’s heart attack risks, the FDA demanded a Class I Recall of the product in June 2012, seven months after Fresenius documented the dangers. Fresenius could have prevented countless people from suffering heart attack and death if it had notified the FDA of the risks earlier.
Facts About GranuFlo Injury
- GranuFlo-induced heart attack or sudden cardiac death usually occurs within 48 hours of dialysis treatment.
- Fresenius has more than 1,800 medical centers across the U.S.
- Fresenius clinics may be operated under different names. Contact us to find out if your clinic is affiliated with Fresenius.
- GranuFlo and NaturaLyte products are also used at clinics not owned by Fresenius. According to a New York Times exposé, Fresenius never warned these clinics of the heart attack risks.
Did You Suffer a Heart Attack after Undergoing Dialysis Treatment?
If you experienced a heart attack or if your loved one suffered sudden cardiac death within 48 hours of receiving dialysis, it may have been caused by GranuFlo or NauraLyte components. Please contact the qualified GranuFlo attorneys at Oshman & Mirisola to learn more about your legal rights and options. We offer a free, no-obligation consultation during which we listen to your story and determine the best way to help you and your family.
What is GranuFlo?
GranuFlo and NaturaLyte are acid concentrate components of dialysate. This product is used in hemodialysis treatment of acute and chronic kidney failure, during which patients’ blood is cleaned. Dialysis may be used to treat other conditions. Patients will not likely know whether their dialysis treatment used GranuFlo or NaturaLyte. Our experienced attorneys can conduct a free investigation to find out. Contact us today to get the compensation and justice you deserve!
What will my Compensation Cover?
Our attorneys will fight to obtain compensation for burdens associated with your GranuFlo injury or loss, including:
- Medical Bills
- Future Treatment
- Lost Income
- Physical Pain
- Emotional Suffering
There is no time to waste. Contact us today to find out if you are eligible for compensation.