Medtronic Recall

CALIFORNIA MEDTRONIC RECALL LAWYER
MEDTRONIC SPRINT FIDELIS CARIDAC LEAD RECALL


WHAT IS A MEDICAL DEVICE RECALL?
A recall is an action taken when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

WHAT IS A DEFECTIVE PRODUCT / PRODUCT LIABILITY?
The law protects people against defective products, and those who are affected by the Medtronic Sprint Fidelis cardiac lead recall may have a product liability case. Product liability refers to a manufacturer or seller being held liable for placing a defective product in the hands of consumers.

AN OVERVIEW OF THE MEDTRONIC RECALL
Medtronic has issued a recall of Sprint Fidelis Cardiac Leads, and has advised patients to consult with their doctors. Medtronic has also advised physicians to stop implanting the leads and to return unused products to Medtronic. The FDA considers this removal action to be a medical device recall. The leads are manufactured by Medtronic and are wires that connect a cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. When functioning properly, defibrillators deliver a potentially life-saving shock if the heart starts beating in an irregular rhythm known as a ventricular fibrillation. A shock from an IDC or CRT-D can restore a normal rhythm to the heart and prevent a heart attack. The devices are being recalled because of potential for lead fractures. If the Medtronic Sprint Fidelis lead were indeed faulty, it could deliver a huge and painful shock to a patient when no shock is required. More dangerously, the device could fail to deliver a shock when the heart is fibrillating, thereby resulting in death of the patient.

WHICH MEDTRONIC SPRINT FIDELIS LEADS HAVE BEEN RECALLED
The following model numbers of the Medtronic Sprint Fidelis family of defibrillator leads have been recalled:

  • Medtronic Sprint Fidelis 6930
  • Medtronic Sprint Fidelis 6931
  • Medtronic Sprint Fidelis 6948
  • Medtronic Sprint Fidelis 6949

WHO IS AFFECTED?
Worldwide, around 268,000 Medtronic Sprint Fidelis leads have been implanted and over 172,000 Sprint Fidelis leads have been implanted in the United States.

WHAT SHOULD I DO?
If you or a loved one has a Medtronic Sprint Fidelis lead implanted, you should consult with a personal injury attorney as soon as possible. Greenberg & Rudman LLP has successfully handled many product liability and defective product cases. Please call us at (800) 252-9776 or contact us online for a free consultation to learn about your rights. You may be entitled to monetary compensation. The FDA recommends that patients who have had the Sprint Fidelis leads implanted should contact their physician.

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