Washington, Lloyd & Henderson, P.C.
1429 2nd Ave North
Bessemer, AL 35020
  Home Attorney Profiles Areas of Practice In the Press Disclaimer Contact Us
Product Liability
  Defective Medical Devices
Guidant Defibrilators

On Friday, June 17th, 2005, Guidant Corporation announced a recall of the following medical devices / implantable cardiac defibrilators (ICDs) :

  • PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002
  • CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004
  • CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004

There are approximately 50,000 patients in the United States with one of these recalled defibrillators. Guidant Corp. has said that the devices have malfunctioned at least 45 times, causing two deaths. Recalls linked to ICD's are not uncommon, and with heart disease still the number one cause of death in the United States, the safety of these medical devices is of great concern.

These surgically implanted defibrillators can develop an internal short circuit without warning, resulting in failure to deliver a shock when needed. The devices are implanted under the collarbone and wired to the heart of patients suffering from life-threatening heart arrhythmia (abnormal rhythm). When functioning properly the units can detect when the heart is beating out of rhythm, and deliver a series of electrical shocks to correct the arrhythmia.

The recall is linked to a potential flaw where some could short circuit and not work at all. So, at the very moment when the patient's life depends on the reliability of the ICD, the device can malfunction.

If you have one of the recalled Guidant defibrillators, contact your doctor immediately to discuss your medical options. For any given patient there are numerous alternatives, your cardiologist can recommend an appropriate course of action individualized for the patient's health concerns. If you feel an electrical shock from a device, or if there is an audible beeping coming from the device, it may mean the defibrillator is damaged.

FDA advises patients to take the following steps:

  • If you have not already been notified, contact your doctor to determine if you have an affected PRIZM 2, CONTAK RENEWAL, or CONTAK RENEWAL 2 device.
  • Continue to keep your regular doctor appointments.
  • If you feel an electrical shock from your device, immediately contact your doctor.
  • If there is an audible "beeping" from your CONTAK RENEWAL or RENEWAL 2 device, immediately contact your doctor or go to the nearest emergency room. Beeping may mean that your defibrillator is damaged.

Guidant also recently informed FDA that it is recalling another set of defibrillator devices called PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT. The company has said the devices are subject to a memory error, which may affect device performance.

Links with more more information: http://www.fda.gov/cdrh/medicaldevicesafety/atp/071405-guidant.html

If you or a loved one would like to discuss your legal rights, please call our law offices or, Click here to request a free legal consultation:
 

copyright© 2005 Washington, Lloyd & Henderson, P.C.