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Why did Guidant Recall its Heart Defibrillator and Pacemaker?
In June and July, 2005, Guidant Corporation revealed that problems with 28,000 implanted pacemakers may necessitate removal of the devices. Later, Guidant Corporation announced a recall of nearly 50,000 heart defibrillator medical devices. Those devices are:
- Pulsar Max II
- Pulsar
- Discovery
- Meridian
- Discovery II
- Virtus Plus II
- Intelis II
- Contak TR
- Ventak Prizm 2 DR
- Contak Renewal 1 and 2
- Ventak Prizm AVT
- Vitality AVT
- Renewal 3 and 4 AVT.
- Contak Renewal 3 and 4
- Renewal RF
Why are they dangerous?
The FDA has classified some of the devices subject to the recall under the "highest priority" designation. Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said: "Malfunctions of these devices can lead to serious consequences and it's important for patients to call their doctor for additional information and personalized advice.”
Guidant has indicated it would replace approximately 28,900 of the devices already implanted in patients. An additional 21,000 devices can be corrected by external reprogramming.
So far, the devices are attributed to at least 45 failures, including two deaths.
What should I do if I have one of the faulty Heart Defibrillators or Pacemakers?
Patients who have been implanted with one of the devices are urged to consult their physician to discuss the benefits and risks of removing the potentially defective devices.
Free Case Evaluation!
If you have become ill, or a loved one has passed due to a damaged heart defibrillator or pacemaker, contact Villari, Brandes & Kline now for a free consultation because time is of the essence to protect your legal rights. Complete a FREE Consultation Form online or Call Us today toll free at 1-888-729-2901!
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