Guidant Pacemaker & Defibrillator Recall
The United States Food and Drug Administration has determined that the safety
advisory issued on June 17, 2005 by Guidant Corporation is classified as a Guidant pacemaker and defibrillator recall.
 |
On Oct. 15, 2007, Medtronic suspended all sales of Sprint Fidelis leads. Please click here to read more about the Medtronic recall. |
 |
|
Two Guidant safety communications were issued to its customer physicians concerning
important safety information related to its medical product devices, including defibrillators.
The Guidant Recall communication on June 17 related to both the Guidant defibrillator (ICD) and
Guidant cardiac resynchronization therapy (CRT) devices. The safety advisory communication
on June 24, 2005 related to the safety of cardiac resynchronization therapy devices.
Click here for a complete list of all the defective Guidant products.
"Pacemaker Recall" Clarification – September 28, 2006
The Heart Rhythm Society has been working closely with the FDA and the manufacturers of cardiovascular medical devices
to clarify any confusion associated with safety warnings issued for Guidant and Medtronic cardiovascular medical devices.
Although there remains a serious risk to patients implanted with any of the affected medical devices, the FDA is
considering softening their rhetoric with regard to the issuing of warnings. The Heart Rhythm Society has suggested that the term
"recall" be replaced with some other phrase such as "advisory notice" or "safety alert." Such a change has been welcomed
by the FDA, the American College of Cardiology Foundation, the International Coalition of Pacing and Electrophysiology
Organizations and the American Heart Association.
The clarification has been recommended to combat the high volume of patients implanted with pacemakers and
ICDs requesting the removal of their device for fear of malfunction. As it is, only a small percentage of
devices have proven faulty, and the surgery to remove an implanted device could potentially cause more of a
health threat, especially if said device is functioning properly. It is believed that a softening of the rhetoric
could alleviate such unwarranted concerns.
Guidant Recall Issued – April 11, 2007
Another Guidant recall has been issued for some 73,000 defective ICD and CRT devices. Batteries designed to last for a
minimum of two years were failing after as little as three months. The rapid depletion of battery-life could potentially
result in premature device failure. Of the 73,000 (+) devices involved in the recall, 19 defective models have been found.
No serious injuries or deaths have been reported as a result of the defects; however, Guidant felt the recall was a prudent
measure designed to avoid any such incident.
Guidant Pacemaker and Defibrillator Products
Guidant is a large manufacturer and distributor of implantable cardioverter defibrillators (ICD) and
devices for cardiac resynchronization therapy (CRT). These devices are used to treat abnormalities in
heart rate and heart rhythm in patients who have heart disease or heart failure. The devices are designed to
be implanted in the chest area and monitor heart function. If an irregularity is detected, then an
electrical impulse (shock) or a series of impulses are delivered to various parts of the heart to restart
normal function.
Guidant-Related Deaths
Heart disease continues as one of the biggest killers in the United States. Heart failure, also known as
cardiac arrest, occurs when the heart stops pumping blood properly. This illness leads to 200,000 to
400,000 deaths per year.
The Guidant devices are designed to extend the lives of heart disease patients,
but if a defibrillator is defective, it could have devastating effects, including patient death.
When the Guidant devices are defective, either the irregularity of the heart rate is not detected
or the proper electrical impulses for treatment are not delivered to the heart. If the proper therapy
is not provided, the heart can cease proper functioning and the patient could perish or suffer
serious injuries due to lack of proper blood flow.
It is Guidant's responsibility to maintain the highest quality standards for their
pacemaker and defibrillator products and insure that if any quality issue arises,
immediate steps are taken to protect the patients. Two deaths have been reported to date
related to the Guidant defibrillator recall defect.
About the Sponsors of this Pacemaker and Defibrillator Information Website
If you or a loved one has been injured due to a defective pacemaker or defibrillator product manufactured by Guidant, you
may be entitled to compensation. The sponsors of this website are attorneys who specialize in helping those who have been injured
by defective products. Please contact our offices today so that one of our Guidant lawyers may answer any questions that you
have and provide a free case review if needed. Our toll-free number is 888-255-AWKO (2956).
If warranted, we can file a Guidant lawsuit to help obtain the proper compensation.
The sponsors of this website include: Aylstock, Witkin & Sasser, Guidant Litigation Group; Neblett, Beard & Arsenault;
Andrus, Boudreaux, Lemoine & Tonore; Lundy & Davis, LLP; and Barrios, Kingsdorf & Casteix, LLP.
|
