Recalled Heart Devices
The information on this page is provided for informational purposes only. As of 2011, the Simmons firm is no longer accepting cases involving recalled heart devices.
Filing a lawsuit
The Simmons firm has experience in litigating complex medical matters. We have taken a leadership role in standing up for individuals who have been injured by dangerous or defective drugs and devices and over the last few years have represented thousands of pharmaceutical clients and recovered verdicts and settlements totaling more than $200 million.*
If you have concerns about your implanted heart device, we encourage you to talk to your doctor right away to see if it is part of the recall.
Types of Recalled Heart Devices
Thousands of people around the world rely on implanted heart devices like defibrillators to keep their hearts beating at a regular pace. In most cases, these devices have, quite literally, saved lives. Unfortunately, many of the implanted devices have turned out to be defective.
In fact, because of the many defective devices, the two largest manufacturers of heart devices, Guidant Corporation and Medtronic Incorporated, along with the FDA, have issued recalls and notices to warn users of these unsafe products, including:
* Please note that recovery results vary per client. The recovery amounts in each case reflect the specific facts of that case. Further, recovery amounts in past cases are not a guarantee of future results.
Timeline of Events
April 4, 2004 - FDA issues Class 1 Recall for the Medtronic Micro Jewel II Model 7223 Cx and GEM DR Model 7271 ICDs.
April 16, 2004 - Medtronic announces a nationwide, voluntary recall of a small subset of 7223 and 7271 ICDs.
February 10, 2005 - Medtronic voluntarily notified physicians about the extremely low potential for a battery shorting that may occur in some of the company’s implantable devices.
May 23, 2005 - Guidant was contacted about a New York Times article that was set to run the following day entitled “Maker of Heart Devices Kept Flaws from Doctors.”
May 24, 2005 - Guidant issued an advisory to physicians concerning a flaw in the Ventak Prizm 2 Model 1861.
June 17, 2005 - Guidant initiated a worldwide physician communications regarding important safety information and correction action about the 1861 and various other devices, which was classified as a recall by the FDA. This was the first of many recalls initiated by Guidant and the FDA.
April 22, 2006 - Boston Scientific completes its combination with Guidant Corporation to create one of the largest medical technology companies in the world.
June 23, 2006 - Boston Scientific issued recalls or warnings on almost 50,000 Guidant cardiac devices and acknowledged it could take as long as two years to fix its safety problems.
How do I know if I have a recalled device?
To determine if your device is included among the recalled models, you can do one of the following:
- Contact your physician.
- Contact technical support for the device manufacturer: Guidant 1-866-484-3268 or Medtronic 1-800-551-5544.
- Visit Guidant’s website.
What should I do if I have one of these devices?
If you have questions or concerns concerning the functionality of your device, discuss them with your doctor. Your physician will consider your medical history and your dependency on your device to determine and discuss with you what is the best course of action.
Glossary of Terms
Defibrillator: a device for correcting life threatening rhythms (ICD, AICD).
Pacemaker: a device for increasing a slow heart rate.
Interrogation: to obtain information from a device.
Ventricle: the lower pumping chamber of the heart.
Atrium: the upper chamber of the heart.
Ventricular Tachycardia: fast heart beats from the bottom of the heart.
Ventricular Fibrillation: rapid, irregular heartbeat.
Cardiomyopathy: a disorder of the heart muscle.
Heart Failure: in general, a decreased pumping ability of the heart.
Myocardial Infarction: death of heart muscle.
Leads: the wires going from a device to the heart.
Cardiac Resynchronization: the use of a specialized device for the treatment of patients with heart failure (CRT, CRT-D, CRT-P).
Syncope: sudden loss of consciousness.