BACKGROUND
Guidant Corporation, one of the largest medical device manufacturers, has recalled over 50,000 Implanted Cardiac Defibrillators (ICDs) and over 87,000 pacemakers due to a life threatening defect in these products.

On June 17, 2005, Guidant recalled some of their ICD models and, on June 24, 2005, additional models were added to the recall list. Guidant said it has determined that a magnetic switch in these devices 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. Furthermore, the devices could, without warning, develop a short circuit that would prevent them from delivering the shock when needed.

Replacement is not simple. An interventional cardiologist must open the chest, remove the lead wires from the heart, put new leads in, and close the patient. Risks of infection and other complications are always present.

On July 18, 2005, Guidant recalled or issued warnings for more than 160,000 pacemakers. The pacemakers have a leaky seal that causes the defibrillator to short out and fail. The bad circuitry has also caused the heart device to fire up and pace at a high rate, putting a potentially fatal strain on a weak heart.

The FDA announced that the affected devices would be classified under the highest recall priority designated by the agency, a Class I recall. The FDA defines a Class I recall as a situation in which there is reasonable probability that the use of, or exposure to, the product will cause serious adverse health consequences or death.

HEALTH RISKS
Guidant has known of these reported problems for some time, but failed to inform doctors or patients. Guidant has admitted that the actual number of failures may be higher than the number so far reported. Further, they admit that the associated deaths may also be underreported, as implantable cardio-defibrillators are not routinely evaluated for product malfunction after a patient’s death.

Guidant has offered to provide a replacement device for free. While that is a significant offer, considering the ICDs cost up to $35,000 each and pacemakers cost up to $25,000 each, it still leaves someone picking up the tab for doctors’ fees and hospital charges, which average $23,000.

Guidant fails to take into consideration that replacement surgery is potentially dangerous for the patient and that the patient must endure the recovery process, downtime, and pain and suffering. Furthermore, Guidant does not consider the patient’s right to choose whether or not to replace with a Guidant product or to purchase from another manufacturer.

DEFECTIVE DEVICES
The defective Guidant Cardiac Defibrillator models include:

• Contak Renewal AVT
  
• Contak Renewal 3 & Renewal 4
  
• Contak Renewal 3 AVT & Renewal 4 AVT
  
• Contak Renewal RF & RI
  
• Contak Renewal Model H135
  
• Contak Renewal 2 Model H155
  
• Ventak Prizm 2 DR Model 1861
  
• Ventak Prizm AVT
  
• Vitality AVT

The following Guidant pacemakers are the subject of the advisory warning:

• 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 1180, 1181, 1280
  
• Discovery II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
  
• Virtus Plus II Models 1380, 1480
  
• Intelis II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499
  
• Insignia All Models
  
• Contak TR Model 1241

Cardiac resynchronization therapy defibrillators:

• InSync I Marquis
  
• InSync II Marquis
  
• InSync III Marquis
  
• InSync III Protect 7277
  
• InSync III Protect 7289

If you or a loved one have one of the recalled ICDs or Pacemakers whether or not the device has malfunctioned and you would like to speak to an attorney about your legal rights, you can call 1-800-324-3036