On May 12, 2006 Guidant Corporation in association with the U.S. Food & Drug Administration (FDA) issued a recall of a large number of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The recall affected the popular VITALITY® HE defibrillators.
Guidant Corporation Comments: The most common way to implant an ICD or CRT-D is subcutaneously (just under the skin). But sometimes, a doctor may instead choose to implant a device subpectorally (under the chest muscle). A doctor may also choose to implant the device facing either toward or away from the ribs. There are good reasons for each of these options, and you can be assured that your doctor has chosen the best option for your individual needs.
The safety information in this letter applies only to those VITALITY HE and CONTAK RENEWAL 3 and 4 devices that are implanted subpectorally and facing toward the ribs—a very rare position. In some cases, devices implanted in this way may malfunction. That is, the device may be unable to deliver appropriate therapy or unable to communicate with the programmer. In addition, your doctor may see a warning on the programmer screen when he or she checks your device. Keep in mind that the large majority of patients who have VITALITYHE or CONTAK RENEWAL 3 or 4 devices are not at risk for this problem.
Do I Have a Guidant VITALITY® HE Recall Lawsuit?
If you or a loved one have a Guidant VITALITY® HE defibrillator, regardless of whether or not you have experienced device malfunctions or failure, you should contact us immediately. You may be entitled to compensation and we can help.
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