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FDA Drug & Medical Device Recall News & Comments 
Monday, 09 November 2009

Edwards Lifesciences Corporation, CardioVations EndoClamp Aortic Catheter
Recall Class: Class I
Date Recall
Initiated: September 24, 2009
Product: CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65

This product was manufactured from August, 2008 through August, 2009 and distributed from November, 2008 through September, 2009.
 
Use: The device blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures.
Recalling Firm: Edwards Lifesciences Corporation
6864 South 300 West
Midvale, Utah 84047
Reason for Recall: The balloon catheters may spontaneously rupture during surgery.
Public Contact: Customers may contact the company's Customer Service Organization at 1-800-424-3278, Monday through Friday, 6:00 a.m. - 4:30 p.m., Pacific Time.
FDA District: Denver
FDA Comments: On October 29 , 2009, the company sent a follow up letter to their customers instructing them to:

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

POSTED BY: DW AT 10:37 pm   |  Permalink   |  E-mail this
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Also see: http://www.fda-recalls.us/

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NSF from MRI Gadolinium Contrast Dye in Kidney Failure, Dialysis Patients & Renal Failure  The FDA has reported a possible link between NSF/NFD, kidney failure and renal failure and the exposure to MRI dye / contrast called gadolinium. Patients with kidney disease, kidney failure, kidney or renal insufficeincy and kidney patients on kidney dialysis, may have contracted a horrible fibrosing skin disease from the gadolinium based contrast dyes used in MRIs. These MRI dyes have serious side effects which includes a rare skin, muscle & joint disorder called Nephrogenic Systemic Fibrosis (NSF). Patients with NSF often develop large areas of hardened skin with fibrotic nodules and plaques, reddened skin, muscle tightening, muscle weakness, joint pain and burning in joints along with itchy, thick areas of skin, usually on one's limbs. Click here for more information about Nephrogenic Systemic Fibrosis (NSF)  Recent reports link fractured femurs to the use of Fosamax. If you have fractured your leg or femur and have taken fosamx get a free case evaluation at www.fosamax-femur-fractures.com Fosamax Femur Fracture Lawsuits Fosamax Lawsuits Recent RFDA Depakote alert warns of Depakote use during pregnancy. Depakote may cause harm to the fetus resulting in spinal bifida, neural tube defects, growth retardation and other birth defects. For more information see depakote spina bifida  FDA warning Reglan may cause Tardive Dyskinesia (TD) a rare side effect of long time Reglan usage. Reglan has been linked to Tardive Dyskinesia. Tardive Dyskinesia is a central nervous system disorder characterized by involuntary movements of the limbs as well as twitching of the face and tongue similar to Parkinson's disease. See Metoclopramide and Tardive Dyskinesia TD for more information about reglan side effects. See Reglan Tardive Dyskinesia (TD) side effects lawsuits. Dilantin can cause SJS Stevens Johnson Syndrome and TENS. Get more info about Dilantin SJS Stevens Johnson Syndrome Lawsuit  Dilantin also can cause TEN (Toxic Epidermal Necrolysis) are more severe than others. Erythema multiforme minor is the milder form of SJS and not as serious as Erythema multiforme majoris. However, full blown Stevens-Johnson syndrone. If you or a loved one have taken Dilantin (phenytoin),Tegretol (carbamazepine), Lamictal (lamotrigue) or Levaquin (levofloxacin) and have been diagnosed with SJS or TENS or a loved one has died for complications of SJS Syndrome or TEN, Stevens-Johnson Syndrome (SJS) is a life-threatening condition affecting the skin in which cell death causes the epidermis (the outer layers of skin) separating from the dermis (inner layers of skin). See information about Stevens-Johnson Syndrome (SJS) Dilantin Lawsuit.Talk to a Dilantin SJS Dilantin Stevens Johnson Syndrome SJS Dilantin TEN lawyer about Dilantin TEN Toxic Epidermal Necrolysis Diagosis and your legal rights to a Dilantin lawsuit .Byetta Pancreatitis Lawsuits Toyota Gas Pedal Recall News

 

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