News and Industry Alerts
FDA Class 1 Recall: Medtronics’s Sprint Fidelis® Defibrillator Leads
On October 15, 2007, the FDA issued a Class 1 Recall on Medtronic’s Sprint Fidelis Defibrillator Leads, which have been implanted in over 200,000 patients since 2004. The Leads involved in the recall were manufactured from September 2004 though October 15, 2007, and have model numbers 6930, 6931, 6948 and 6949.
Medtronic Inc. Leads are thin wires that are connected from an implanted defibrillator directly into the heart. In patients, they are used to treat dangerous abnormal heart rhythms that could cause the heart to stop beating. In some cases, these leads can exhibit small fractures. If a lead breaks due to the fractures inappropriate shocks may result; which would cause a loss of effective therapy and in some instances death. Patients who are implanted with this type of lead should contact their doctor to determine whether their lead is defective. Patients may also call Medtronic Patient Services at 1-800-551-5544 x41835 with their concerns.
FDA Class 1 Recalls are the most serious and involve products that have a reasonable probability of causing catastrophic injury and even death. Medtronic has issued a statement to physicians asking them to stop implanting the leads immediately and to return/discard any unused products to the company.
If you or a loved one has been seriously injured as a result of Medtronic’s negligence please do not hesitate in contacting Messa & Associates for a free consultation 215-268-3500.
Additional information can be found on the FDA’s website:
Medtronic Recalls Sprint Fidelis® Cardiac Leads Questions and Answers for Consumers
Class 1 Recall: Medtronic Inc. Sprint Fidelis® Defibrillator Leads
And on Medtronic’s home site at:
Important Patient Information Sprint Fidelis® Lead Performance
