BACKGROUND
Guidant Corporation, one of the largest medical device manufacturers, has recalled over 50,000 Implanted Cardiac Defibrillators (ICD's) 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 tachyarrhthmias 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 cardiologists 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.
Minneapolis-based Medtronic announced the recall of approximately 65,000 implanted defibrillators in the U.S. in February 2005. The units have defective batteries, which creates a risk of sudden failure.
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 a 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 this is a significant offer, consider the ICD's cost up to $35,000 each and pacemakers cost up to $25,000 each, it still leaves someone picking up the tab for doctor's 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 and Renewal 4
- Contak Renewal 3 AVT & Renewal 4 AVT
- Contact Renewal RF & RI
- Contak Renewal Model H135
- Contact Renewal 2 Model H155
- Ventak Prism 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, 1080, 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
Medtronic defective models include:
Implantable cardiovertex-defibrillators;
- Marquis VR 7230
- Marquis VR 7274
- Marquis DR 7274
- Maximo VR 7232
- Maximo DR 7278
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 on have one of the recalled ICD's or Pacemakers - whether or not the device has malfunctioned - and you would like to speak to a product liability attorney about your legal rights, you can call 1-800-658-1596.
