Guidant Recall
Guidant Recall - Guidant claims that it discovered a short circuiting defect in 2002 and altered the manufacturing process of the devices that year to correct the defect.
However, Guidant continued to sell the old defective devices without notifying doctors that improved devices were available. Defibrillators cost approximately $25,000 apiece. Guidant's 2004 defibrillator sales totaled $1.8 billion, signaling that until recently, Guidant may have been more motivated by profits than by patient safety. If you feel you have a case regarding the usage of a Guidant Pacemaker, fill out our case form for a free, no risk evaluation.
On January 21, 2006, Guidant Corporation sent correspondence to patients regarding certain Guidant pacemakers manufactured between October 27, 1997 and December 5, 2000. Individual physician and FDA notifications have been issued along with the patient advisory. The problem arises from a "gradual degrading of a seal used in a subset of these devices" which results in a "higher than normal amount of moisture entering the pacemaker case."
Guidant has determined that several patients have experienced loss of consciousness and possible heart failure.
Heart patients with a defibrillator who are unsure if their device is one of the malfunctioning models should contact their doctor as soon as possible to determine if their model requires replacement, can be reprogrammed, or whether it is even slightly affected by the recently announced safety issues. To learn more about whether your device is affected by the recall, contact Guidant directly at 1-866-GUIDANT (1-866-484-3268)
View a complete list of models recalled by
Guidant.
The following is a list of potential risks and complications associated with the recalled ICDs manufactured by Guidant:
Serious complications from the pacemaker and defibrillator surgery include:
- Death
- Heart attack
- Stroke
- Electrical storm
- Puncture of lung or heart muscle
- Torn blood vessel
- Severe bruising or bleeding
- Air intrusion between lungs and chest wall
- Short circuiting
- Magnetic switch problems
- Computer memory problems
Less serious complications for Guidant pacemakers and defibrillators include:
- Chest pain
- Palpitations
- Fainting
- Shortness of breath, prolonged hiccupping, difficulty breathing
- Redness, warmth, tenderness, or swelling of the incision site
- Drainage of liquid from the incision site along with fever
Guidant Corporation has advised patients to take the following steps in regards to the recent recalls and warnings:
- Contact your doctor to determine if you have an affected ICD.
- Contact your doctor if you feel an electrical shock from your device.
- Contact your doctor or go to the nearest emergency room if you hear an audible "beeping" from your ICD.
The FDA concurs with Guidant's proposed recommendation to patients, which are consistent with the physician recommendations previously set forth in Guidant's letter issued July 18th:
- If you believe you are pacemaker dependent, contact your physician soon to discuss your treatment options.
- Continue your normal doctor appointments.
- If you experience symptoms of shortness of breath, dizziness, lightheadedness, loss of consciousness, or a prolonged fast heart rate, you should consult with your physician or go to the emergency room immediately.
- If you are not sure which model you have, or if you have other questions regarding your device, you should consult with your physician.
- If you know your device's model and serial number and want to find out if it is affected by the leakage problem, you can check www.guidant.com/webapp/emarketing/lookup.jsp or contact Guidant Technical Services at 1-866-GUIDANT (1-866-484-3268).
Morgan & Morgan attorneys believe persons injured by Guidant deserve full compensation for resulting medical bills, pain and suffering, lost wages, and other damages.