The U.S. Food and Drug Administration (FDA) has issued a Class 1 recall concerning a defibrillator lead that can lead to death from a defective heart rhythm. The device is made by St. Jude Medical and the FDA notified health care providers of the most serious recall of the Riata and Riata ST Silicone Endocardial Defibrillation Leads. The problem is that the silicone that insulates the covering is defective and may cause the leads to come out of the insulation. This is when a lead has the potential to misfire. The implantable cardioverter defibrillator, or ICD, is connected to the patient’s tissue through the leads whose job it is to monitor the heart rhythm. In the case of an irregular heart rate, the defibrillator, if connected properly, will deliver a jolt to encourage a regular heart rate.
The particular defibrillator leads listed in the Recall Notice says they were distributed from June 2001 to December 31, 2010, so the recall could affect thousands of patients.
St. Jude has notified physicians by certified mail of the failure rate, which the FDA does not include in this Safety Notification. As far as patients who are living with the implanted leads which could be faulty, the FDA reminds doctors that they must manage patients with this particular implant and that the doctor can report any adverse events to the FDA’s MedWatch program, which may give patients with a potentially defective implanted lead little peace of mind.
A Class 1 recall is conducted when the defective device has the potential to cause serious harm or death to a patient.
Product Liability and Medical Devices
A responsible drug or medical device manufacturer should understand their product fully before it is put into the marketplace, including any defect in the manufacturing and design, including materials used, or in a failure to adequately warn users of the product. When a company fails to do so and patients are injured, that company needs to be held accountable. Product liability litigation may ultimately be the reason a dangerous device is removed from the market.
The defective medical device lawyers in Jacksonville of Farah & Farah will offer a complimentary consultation to anyone harmed by a drug or medical device that was defective. Call us at 1(800) 533-3555 to get started.
Source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm284390.htm?source=govdelivery; http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm284360.htm