The FDA issued a Class 1 Recall for Medtronic Incorporated's device named Sprint Fidelis® Defibrillator Leads
The model numbers of the recalled defibrillator leads are; 6930, 6931, 6948 and 6949. The recalled leads were used in defibrillators manufactured from September 2004 through October 15, 2007. Class 1 Recalls are used by the FDA when there is reasonable evidence to believe that a product or drug may cause serious injury or death.
The Medtronic's Sprint Fidelis defibrillator leads are being recalled due to a small number of fractures which have been found in the devices, which could cause inappropriate shocks or result in a loss of therapy which would lead to a failure of the device to perform its normal functions, with health risks to the patient. The Sprint Fidelis "Leads" are very thin wires connecting the implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) to the heart. These devices (ICDs and CRT-Ds) are used to treat abnormal heart rhythms which can result in sudden and dangerous heart stoppage which may cause death or serious injury. If you or a family member has suffered an injury as a result of this (or any other defective medical device) you may request a free consultation with an attorney
Just prior to this Class 1 recall, Medtronic issued their own "voluntary suspension of sales and marketing
" of the Sprint Fidelis Defibrilator Leads.
Medtronic has instructed doctors and hospitals to stop using the product, and to return any leads with these models to the manufacturers. Patients with the devices may call Medtronic Patient Services at 1-800-551-5544 X41835 (7 am to 9 pm Central Standard Time). If you have a Medtronic device and are unsure of the model number or whether it has potential to be defective, consult your physician and obtain your medical records.Additional information from the FDA regarding Medtronic Recalls
manufacturer Medtronic recalled two models after receiving several reports that the devices do not charge properly and fail to shock a patient's heart when required. Medtronic is removing Micro Jewel II Model 7223Cx
and GEM DR Model 7271 ICD
s due to malfunctions that have been linked to four deaths and one injury. The company says the defibrillators are taking a dangerously long time to charge.
According to Medtronic, over 6,000 of the recalled models were manufactured and implanted in 1997 and 1998. Nearly 2,000 are suspected to still be in use. The company has alerted physicians
to test the charge capability of Micro Jewel and GEM model defibrillators implanted in patients.
Medtronic requests the sealing of records involving a defective product lawsuit
filed on behalf of a woman who was put in a coma as a result of an injury alleged to have been created by the defective device.
If you have experienced serious health problems due to a cardiovascular device, it may be important to contact an attorney
who can help you protect your legal rights. Please keep in mind that there may be time limits
within which you must commence suit.Attorneys associated with InjuryBoard.com
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