Viles & Beckman, file class action lawsuit against Guidant over faulty defibrillators and pacemakers

4 October 2005

Fort Myers, Fla, USA. US law firm Viles & Beckman, LLC has filed a class action product liability lawsuit against Guidant Corp., one of America's largest manufacturers of medical devices. The complaint states that Guidant Corp. learned well in advance of the recall that their devices were faulty, but delayed notification to physicians and the general public hoping that future models would correct any flaws. Subsequently, two cases of death associated with Guidant's recalled pacemakers have already been reported to the FDA.

On June 17th, 2005, Guidant Corp. announced that it would recall nearly 50,000 Implantable Cardiac Defibrillators distributed worldwide due to faulty insulation in the wiring. Defibrillators, which are largely used by people who suffer from life-threatening arrhythmia or an irregular heartbeat, are designed to emit a life-saving electrical shock to the heart to restore normal rhythm. Faulty insulation in the wiring of the defibrillator has the potential to cause short circuits and prevent the device from shocking the heart during a cardiac event.

The following defibrillator devices were affected by the recall:

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

On July 19, 2005, Guidant Corp. announced a second recall affecting approximately 28,000 patients worldwide.

Pacemakers are also implantable devices that are designed to electrically stimulate the heart. The difference is that pacemakers emit electrical shocks to the heart causing it to contract and pump blood when the heart's electrical system is dysfunctional, whereas defibrillators shock the heart when an irregular heartbeat is sensed. The flaw resides in the hermetic seal on some Guidant pacemaker devices, whereby moisture can seep in and potentially cause damage to the device. There has been at least one death thought to be attributed with this product failure. Guidant has also identified that some of their pacemakers may have a defective magnetic switch which may be stuck in the closed position, hindering the pacemaker from delivering an electric charge when needed.

The following Guidant pacemaker devices, manufactured between November 25, 1997 and October 26, 2000, were affected by the recall:

  • PULSAR MAX Models 1170, 1171, 1270
  • PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
  • DISCOVERY Models 1174, 1175, 1273, 1274, 1275
  • MERIDIAN Models 0476, 0976, 1176, 1276
  • PULSAR MAX II Models 1180, 1181, 1280
  • DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
  • CONTAK TR Model 1241
  • VIRTUS PLUS II Models 1380, 1480
  • INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499

Potentially 78,000 persons may now require surgery to replace defibrillators and pacemaker devices produced and subsequently recalled by Guidant Corp. Some Guidant devices that were not recalled may be subject to a memory error which can also lead to malfunction of the device.

Incorporated in 1994, Guidant quickly became the leading medical device supplier in the United States, earning over 3.8 billion dollars in the past 11 years. Its medical devices were hailed as some of the most dependable machines ever produced, until 2002 when they received some unfortunate news regarding a potential problem with its Ventak Prizm 2 DR (model 1861), indicating that faulty insulation in some of its wires could lead the device to short circuit. Apparently, Guidant was sure this flaw would be corrected in future models, and waited until May 2005 to notify doctors of this potential malfunction. The Contak Renewal (models H135 and H155) made prior to 2004 are also subject to this flaw.

Designated as a Class I recall by the Federal Drug Administration (FDA), Guidant's products may fail to deliver the lifesaving shock during the time when patients would need it most. Class I is the most serious category in the recall system used by the FDA; it identifies a "reasonable probability that the malfunctioning device will cause serious adverse health consequences or death." ( )

Signs of a failing product may include sudden faintness, a loss of consciousness, shortness of breath, dizziness, lightheadedness, prolonged fast heart rate, and heart failure or death.

If you have a Guidant pacemaker but are not sure which model it is, consult your physician with any questions or concerns that you may have. Lastly, if you have experienced any problems with your pacemaker device, please notify the FDA MedWatch program and Guidant Corp. Go to  to file a report on the problem online or call 1-800-FDA-1088 (1-800-332-1088).

About Viles & Beckman, LLC

Viles & Beckman, LLC takes pride in making corporations accountable for their actions. It was the first law firm in the U.S. to file a class action suit against the manufacturers of the diet drug Fen-Phen. It helped lead the successful effort to recall defective tires in the Ford/Firestone class action and has been featured on CNN, MSNBC, Good Morning America and CBS Evening News. They have also been featured in the Wall Street Journal, New York Times, Washington Post and other publications. Viles & Beckman, LLC has been nationally recognized for their extensive work towards defending the rights of the consumer and demand that goliath companies take responsibility for their actions. They hope to promote corporate accountability and to protect the rights of consumers worldwide.

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