Recall Notice
Urgent Class I Recall Notice for the Medtronic Sprint Fidelis
The FDA has annouced that any patients who received a Medtronic Lead in the last three years to seek immediate medical attention for the Medtronic Sprint Fidelis Lead can cause:
- Fainting;
- Palpitations;
- Inappropriate Shocks resulting in Death;
- Lightheadedness;
- Other Unusual Symptoms
What is a Medtronic Sprint Fidelis Lead?
Manufactured by Medtronic, Inc., Sprint Fidelis Leads are specific models of cardiac electrodes (thin wires) that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. ICDs and CRT-Ds are devices that protect patients when life-threatening heart rhythms occur. Our Law Firm is providing patients who have been injured by the Medtronic Sprint Fidelis Cardiac Lead or those that may need a Lead Replacement with information. Please call us for more information. Our Law Firm is also evaluating if those affected by this recall may be entitled to financial compensation. Please complete the form to the left or call 1-800-862-1260.
How do defibrillators work?
Defibrillators monitor heart rhythms. They deliver an electrical shock or rapid pacing to restore normal rhythm when life-threatening, irregular heartbeats are detected. These devices keep the heart from going too fast. They are surgically implanted for patients who are at risk of sudden cardiac arrest. Our Law Firm is providing patients who have been injured by the Medtronic Sprint Fidelis Cardiac Lead or those that may need a Lead Replacement with information. Please call us for more information. Our Law Firm is also evaluating if those affected by this recall may be entitled to financial compensation. Please complete the form to the left or call 1-800-862-1260.
What Doctors Can Do If You Have a Medtronic Sprint Fidelis Lead.
Patients should consider and discuss with their doctors alternative available which include;
- Removing the Medtronic Sprint Fidelis Lead through surgery;
- Continue to use the Medtronic Lead while monitoring closely for signs of fracture;
- Add a replacement lead. This does not require removing the Medtronic Sprint Fidelis lead. If the Spring Fidelis lead is left in the patient without being used, it must be “capped”, which means covering the tip with a small plastic insulation.
