Implanted Heart Devices: Guidant

Guidant Information

In June 2005, Guidant alerted doctors to a recall of 11 of the companies 88,000 defibrillators and issued warnings for 28,000 pacemakers. Guidant pacemakers had a faulty magnetic switch that may get stuck in the closed position, which in some cases inhibits their ability to treat ventricular or atrial tachyarrhythmias and can accelerate battery depletion. These units were made between 1997-2000.

The Guidant devices involved are Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF implantable cardioverter defibrillators, or ICDs:

If you believe that you or a loved one has been adversely affected by one of the implanted heart devices made by Guidant, please fill out an evaluation form. Please provide as much information as possible to speed the processing of your inquiry.

Ricci~Leopold is here to assist you with any communication needs that will help get this important, timely information to the general public.
 
Please call Julie Oseland at (800)699-1914 with any questions you may have.

 Read related information on Medtronics.

BREAKING NEWS:

• 12/28/05 F.D.A. Puts Restrictions on Guidant
• 12/28/05 J&J, Boston Scientific in Bitter Rivalry Over Stent Safety
• 12/27/05 FDA Warns Guidant Over Facility Problems
• 12/25/05 Guidant's Device Failure Rate Revealed
• 11/10/05 Guidant Issues Data on Faulty Heart Devices
• 10/26/05 U.S. Seeks Data on Heart Device Products  
• 09/27/05 Implant Program For Heart Device Was a Sales Spur
• 09/12/05 F.D.A. Had Report of Short Circuit in Heart Devices
• 08/11/05 Patients with Defibrillators face tough choice
• 08/08/05 Another Guidant Warning
• 08/07/05 When a Heart Device Short Circuits
• 08/02/05 As Their Use Soars, Heart Implants Raise Questions

Guidant Information:

• Home Page
• Implantable Defibrillators
• Implantable Cardioverter Defibrillators

FDA Information:

• 10/13/05 Update of FDA Preliminary Public Health Notification
• 09/22/05 Original FDA-483
• 07/22/05 FDA Announces Guidant’s Class I Pacemaker Recall 
• 07/18/05 Guidant Initiates Worldwide Physician Communications
• 07/14/05 FDA issues Preliminary Public Health Notification on Certain Guidant Implantable Defibrillators 
• 07/01/05 FDA Updates Consumers on Guidant Corporation’s Implantable Defibrillators

News Coverage:

• 08/02/05 Guidant Gets Approval to Resume Sales
• 07/30/05 New Report of Problems at Guidant
• 07/19/05 Pacemakers By Guidant Have Flaw
• 07/18/05 Guidant issues warning for 28,000 pacemakers
• 6/17/05 A Issues Nationwide Notification of Recall of Certain Guidant Implantable Defibrillators and Cardiac Resynchronization Therapy Defibrillators 
• 06/24/05 Guidant Recalls Heart Defibrillators
• 06/23/05 Heart Device Maker To Consider Changes
• 06/20/05 Faulty Heart Devices Force Some Scary Decisions